Liaise with suppliers regarding any queries on batch documentation, Participate in QTA and Quality review meetings as required with the Associate, QA Director. To assure drug product, documentation, and data related to the manufacturing, packaging, labeling, and testing of clinical drug and biologic products are compliant with GMP, SOP, IND / IMPD, CTA and other relevant regulatory requirements, 25%: Provide QA guidance for product development projects from Phase I - III. Senior QA Analyst( 03/2011- 01/2012) Confidential is the largest Pharmacy care provider in United States. Quality Assurance Managers make sure products meet certain industry and legal standards. Activities include evaluating change, communicating change other SMEs and Regulatory within the company, approving, and processing the change, Develop and execute change control implementation plans as required, Provide notifications/obtain pre-approvals of change controls to partners where required, Responsible for generation of client requested changes to CMOs and service providers, Perform external GMP and vendor qualification audits, Perform vendor qualification risk assessments, Write audit reports, and follow up on observation close-outs, Develop/revise/implement/adhere to Quality Assurance departmental policies and procedures, Minimum BS Degree preferably in life sciences, or equivalent work experience, Minimum of 5 years’ experience in the pharmaceutical/biotech industry, A GMP background is preferred with experience in the manufacturing of GMP products, Ability to work independently within a fast-paced dynamic team environment, 70%: Responsible for the Execution Global Quality Standards Process, Create Gap Analysis tools related to the Global Quality Standards, Track and report on the status until closure of Gaps to the Global Quality Standards, Maintain in compliance with Shire’s record policies completed Gap Analysis, Creation and reporting of a dashboard for Global Quality Standards to the appropriate governance forums, Work with Regulatory Intelligence to identify possible revisions to Global Quality Standards, Partner with Technical writer to revise documentation as required, Support in the creation, drafting, and revision of Global Quality Standards for Shire, Guide teams in the performance of Gap Analysis activities for new or revised standards, Review team output of Gap Analysis and propose revisions/corrections as necessary prior to sending to Leadership for approval, Work with Process owners ensure metrics are developed for systems which will show the health of the Quality System through the standards process, 15%: Responsible In-Use Monitoring of Quality Standards, Track and report on remediation commitments from process owners and sites and report on adherence to plan to appropriate governance forum, Work with the Process Owners to evaluate system metrics and propose improvements based on the Quality Standard program to ensure standards are In-Use throughout Shire, Act as liaison between sites to help ensure standards are implemented consistently throughout Shire, 15%: Responsible for Integrations of acquisitions into the Quality System, Work with Integration teams to evaluate markets and contents of acquisitions Quality Manual and Quality Management system to ensure seamless integration into Shire Systems, Support, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the context of a virtual sponsor/business partner environment. Participate in the elaboration of local SOPs and execute quality activities such as Change Controls, CAPAs, Deviation Investigations, Mock recall, Complaints, etc. Utilize Six Sigma tools with a structured problem solving methodology to identify root cause and develop corrective actions for failure modes identified through failure analysis, Respond to customer requests for RCCA (root cause / corrective action) by providing comprehensive technical reports based on F/A and RCCA activities, Lead formalized root cause and corrective action teams, managing the team, implementing the improvements and documenting the findings, Host internal and external quality audits (supplier, corporate, and ISO 9001). Cloud experience is desirable, Proficient in MS SQL database and MS SQL Scripting, Ability to manage multiple projects at one time, often with changing requirements as needed, Must be detail oriented, reliable and have the ability to work both in a team environment and alone with minimal direction and supervision, Good interpersonal, written and oral communication skills, Minimum of 5-7 years of progressive experience in a GMP environment required, Minimum of 5 years of Quality Assurance experience in support of GMP production required, Previous exposure to investigations and product complaints required, Must be able to interpret applicable standards and objectively make decisions, Demonstrated ability to stay abreast of trends and new information in the profession, Investigate customer complaints and non-conformance issues through to resolution, Track/Manage status /record keeping for complaints, non-conformances, and corrective and preventive actions, Assess adequacy of quality system documents (including, but not limited to policies, processes, procedures, work instructions, reference material, and forms), Design (new) and draft revisions of quality documents, Evaluate adequacy, interpret, and implement quality assurance standards, Plan, initiate, conduct, and document internal audits, Track and analyze data related to quality system metrics, Prepare reports to communicate outcomes of quality-related activities, Support maintenance of the document and records management processes, Support efforts to maintain and continually improve ongoing compliance with overall quality and industry regulatory requirements, Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, a plus, Strong computer skills including Microsoft Office applications, Knowledge of ISO 9001 and/or ISO 14001, a plus, Experience with implementation of corrective action programs, a plus, Experience with electronic document management system, a plus, Experience with work-flow based quality management system software, a plus, You have a solid theoretical background with an engineering or business degree, or equivalent preferably with quality management focus, You possess solid experience in quality management systems and as lead auditor, exhibiting good auditing skills in a matrix organisation, You have worked with quality concepts such as root cause analysis, cost of quality, QC tools and continuous improvement tools and methodologies, You possess good skills in analysing data, and you have a flair for IT, especially Excel and SharePoint, You speak, read and write Danish and English fluently, High School Degree or equivalent experience is required, Seven years of related experience is required. Find and customize career-winning Senior Quality Assurance Engineer resume samples and accelerate your job search. Quality Assurance Analyst Resume Samples Writing a great Quality Assurance Analyst resume is an important step in your job search journey. Senior Qa Tester Resume. Maintain nuclear grade quality standards by traveling to vendor locations and completing source inspections / audits on in-process manufacturing and finished products. Write an engaging Quality Assurance Engineer resume using Indeed's library of free resume examples and templates. Developed test strategy based on project requirements, project constraints and risk analysis. Nikhil XXXXXXX Mobile No: 9xxxxxxxxx Email Id : nikxxxxxx@yahoo.co.in OBJECTIVE:-A top performing quality assurance manager with a 9 year record of achievement in the IT and Engineering sectors. Download Senior Quality Assurance Specialist Resume Sample as Image file, Quality Assurance Specialist Resume Sample, Quality Assurance Engineer, Senior Resume Sample, Training & Quality Specialist Resume Sample, Specialist Quality Assurance Resume Sample, Senior Manager, Quality Assurance Resume Sample, Senior Specialist, Quality Assurance Resume Sample, Senior Quality Assurance Eng Resume Sample, Manage onsite Clinical Trial client audits from start to finish, In follow up to client audits, track and initiate effectiveness checks for ACM corrective and preventive actions, Identify trends and areas for improvement and provide input to quality area and manager(s) to enhance training or create action plans to address issue(s), Works with the technical development team during the defect resolution process including working closely with the BA and PM during re-testing and validation, Provide continuing support for development, implementation and maintenance of the Pharmaceutical Quality System and supplier management program, Assist with development and monitoring of quality improvement initiatives and quality metrics within laboratories, Positive attitude towards work, environment and co-workers, Provide support for the product artwork process, Work collaboratively with local CDO(s) and Distributor partners; Handle returns, rejects and destruction; and oversee product rework, Provide input to the development of quality tools to be used in the quality review process, Perform other duties as may be assigned by management, Provide support for management of complaints, deviations, CAPA's and change controls associated with commercial products, You’ll design, develops, executes, reports, and debugs functional, mobile, browser, accessibility and localization tests, Evaluate and perform trend analysis and report results for quality metrics. We analyzed 3,640 Senior Quality Assurance Tester resumes to identify the skills, responsibillities, and achievements that hiring managers want to see. FireEye Inc. Reston, VA Senior Software Quality Assurance Manager 07/2015 to Current Managing and leading a team of 25 team member Manual and Automated QA organization.Spearheaded all quality assurance efforts within an organization, including the development and implementation of a quality assurance program.Defined QA policies,quality improvements processes, best … 8539 Olson Parkway, Los Angeles, CA +1 (555) 775 3157. This may include the preparation of Audit Plans, conducting audits and writing Audit reports, Assist with Regulatory and Customer audits as required. QA point of contact for PEGA. Costly Senior Quality Manager Mistakes To Avoid. Senior Supplier Quality Engineer Resume. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience, Strong understanding of regulatory requirements for commercial products, Proven track record with FDA, EMEA and other Health Authorities, Strong Technical understanding of pharmaceutical processes, Team and consensus builder, with definitive and authoritative decision making ability, Ten or more years of experience in an applicable risk management environment, At least ten years of experience in quality control, quality assurance, compliance testing or audit roles for financial services company, Internal and external audit experience in banking industry, Ability to identify and clearly communicate issues, measurement criteria, cause, exposure and recommendations, Advanced to Expert level of presentation (verbal/written), relationship building and persuasion skills, Advanced to Expert understanding of Consumer Banking operations, products/services, systems and associated risks/controls, Advanced to Expert understanding of applicable laws, regulations, financial services and regulatory trends that impact consumers, Comfortable working in a team environment with layers of required review/approval, Prior leadership of staff that perform testing/monitoring activities, Bachelor’s degree in Computer Science, Computer or Software Engineering, or a related field and 5+ years of experience as a manager of high performance quality assurance teams, focused on Wireless Connectivity, 10+ years of industry experience, including at least 3+ years of hands-on testing or test automation and 5+ years as a quality assurance manager, Experience implementing and testing networking and wireless communications protocols; performing distributed systems design and testing; experience with Bluetooth, Wi-Fi and/or ZigBee including understanding of the air interface and MAC layer interactions, Strong experience managing and creating test automation frameworks, Quality Assurance best practices pertaining to test definition, requirements tracking, and test automation, Master’s degree in Computer Science, Computer or Software Engineering, with strong industry knowledge of testing Wireless Connectivity in mobile consumer electronics devices, Strong Experience with testing wireless protocols (Wi-Fi, BT/BLE, ZigBee and/or LTE/UMTS), Manage, staff, and lead a team of Quality Analysts focused on data warehousing, business intelligence, and Java applications, Maintain and implement quality assurance standards within our different Scrum teams, Participate in QA Analyst work to keep up-to-date skillsets and firsthand views on the issues, challenges, and best practices of each team - This person will need to be comfortable with rolling their sleeves up and getting stuck in with their team, Coordinate with appropriate parties to identify and prioritize next steps throughout the incident management process, Effectively advocate and disseminate Quality Assurance best practices in the team, This person will need to be comfortable with rolling their sleeves up and getting stuck in with their team, Extensive experience in software quality assurance on Enterprise Data Warehousing and Business Intelligence projects, Experience with Data Warehousing using the following technologies, Previous experience developing custom Java applications using, Direct responsibility for the corporate quality function, including quality engineering, and the corporate quality management system and tools, Indirect responsibility for site quality organizations across the company, Ensure compliance with national and international quality standards, Define and implement quality procedures in conjunction with operating staff, Support site internal and external compliance audits and drive necessary corrective action completion, Bachelor's Degree in applied science or engineering field, Minimum 5-years prior experience in Quality, Engineering or Operations Management, Demonstrated experience working with manufacturing, engineering and supply chain, Demonstrated exceptional written and oral communication skills, Proven track record of delivering results against objectives, Willingness and ability to travel, as required (up to 25% anticipated), Direct, manage and coordinate the GMP-QA team in the development, implementation, maintenance and improvement of the GMP Quality Systems, Provide day-to-day direction, support and leadership to the GMP QA associates, ensuring that the team has adequate resources and support to meet its responsibilities, Provide performance feedback and management of direct and indirect reports, Provide leadership and direction to the QA team in the absence of the QA Director, Lead and collaborate with the management team of the logistics/distribution department and of other functional areas to review key quality metrics and establish quality improvement initiatives, QC inspection and QA review of logs, products and records, Foreign site quality & GMP compliance review (for imported products), Coordination of PV activities to designated PV parties (for imported products), Maintenance and timely submissions of various regulatory GMP license amendments and renewals (DEL, MDEL, NHP-SL and OCS-LD), Creation and review of Quality Agreements with MAHs/clients and vendors/suppliers, Facility and equipment qualification/validations, Internal audits/self-inspections on GMP facilities and processes to ensure compliance with GMP, client requirements and Innomar procedures, Management of controlled documents (Policies/SOPs/WIs/Forms) request, review and issuance work flow by actively liaising with department management and other reviewers/approvers, Ensure facility and process audits as well as vendor audits are scheduled in advance and reflected in the QA audit calendar, Coordinate and host external audits by clients and/or regulatory agencies, Coordinate audit preparation activities with all impacted business units, Facilitate appropriate, effective and timely provision of documents, responses and actions during the audit, Collate responses and corrective actions with relevant impacted business units to ensure timely resolution of observations and issuance of documented responses, Provide summary and trend analyses on outcome of external audits to senior QA and functional department management, Interact with clients, internal stakeholders, vendors and various project members to ensure that specified business needs are met; assists in the post-implementation analysis to ensure that requirements are fulfilled, Manage the CAPA process for the distribution/logistics department by ensuring that non-conformance and other reportable events as well as CAPA reports are recorded, followed-up, tracked and trended, Identify, monitor and present internal/external audit and CAPA trends to department and QA management teams, Implement continual process improvements related to GMP, warehouse, distribution and regulatory processes as required, Timely submission of billing invoices to Finance for all billable QA/QC activities, Provide quality metrics for assigned areas to the QA Director on a monthly basis and on an ad-hoc basis as requested, Provide guidance to clients and internal stakeholders on GMP matters and serve as a resource to internal stakeholders for the interpretation and application of regulations and applicable guidelines, In coordination with the QA Director, prepare QA budget and manage departmental expenses, Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required, May also be assigned other duties and tasks as required from time to time by the QA Director, Minimum Bachelors of Science degree in chemistry, pharmacy, pharmacology or other related healthcare or pharmaceutical field, Minimum of 15 years’ experience in a senior Quality Assurance function in the pharmaceutical GMP or biotechnology industry, Minimum of 10 years’ experience in management of multiple projects (planning, implementation, management and monitoring) including budget, resource plan, Key Performance Indicators, etc, Minimum of 5 years’ experience each in the following areas, Performing/overseeing facility, process and equipment qualification/validation, Conducting internal self-inspections and vendor audits, Submission and maintenance of Health Canada facility licenses, Product quality review and Canadian QA release of imported products, Industry certification in Quality is preferred. Successfully led two Web Testing project as Project Leader. Guide the recruiter to the conclusion that you are the best candidate for the quality assurance engineer, senior job. Liaise with regulatory agencies as needed to ensure business/regulatory timelines are met, 5%: Review of QC data and CoA approval. 15% Track and evaluate any investigations or deviations that occur during the manufacture of GMP material. All senior specialist, quality assurance resume samples have been written by expert recruiters. Prepare the change control for Internal and External Quality Agreement, Review and Manage temperature excursions and Transport and Distribution deviations, Support GMP\GDP training program for Shire Pharma Canada ULC impacted personnel, Maintain and further develop competence in GMP\GDP through regular training, benchmarking with colleagues, and coaching from Subject Matter Experts, Review and approve artwork for printed packaging materials, Act as a deputy for Shire Pharma Canada ULC Associate, QA Director, University degree or degree recognized as equivalent in Science, Practical experience of at least 3-5 years in the Pharmaceutical Industry, mainly in QA/QC environment, Excellent knowledge of Health Canada cGMP & cGDP regulations, Experience in a global environment (asset), Good degree of autonomy, able to work with limited supervision, Good interpersonal and communication skills, Able to work across levels and functional and geographical boundaries, Bilingualism is required - French and English, Look for practical and compliant solutions to issues, Understands potential impact and contributes significantly to the resolution of simple or complex issues arising, Work with numbers of suppliers / products, Facilitate troubleshooting, and tackle non-routine work and projects independently, Offers constructive comments and propose improvements and rationalizations to systems, policies and procedures, Use judgement to assess which information must be referred upwards and what can be handled independently, Thorough understanding of QSR & ISO requirements, Working knowledge of QA/QC and Manufacturing, Organizational skills, attention to detail and ability to prioritize in a fast paced environment is essential, Work related experience in medical device industry, Manage and mentor QA Specialists in the execution of their tasks & responsibilities. degree in science/engineering, or related field, with at least 5 years relevant experience in a CMO, CRO, or sponsor environment, Quality-focused experience with quality systems experience, Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, and EMA regulations as related to pharmaceutical manufacturing, Required to travel internationally and domestically, (travel up to 15%), A minimum of a B.S. Follow up with functional department for timely completion of corrective and preventive actions recommended, Serve as the quality operational technical representative on project teams evaluating new documentation processes or systems, Perform assessments of raw material changes, process/manufacturing changes, and equipment/utility changes with relevance to regulatory filings and quality agreements. This includes communicating directly with internal project teams and customer contacts, Participate in self-development activities and training of personnel in other departments, including the review of current literature and industry/news trends, Perform other related duties as may be reasonably assigned in the course of business, B.S. quality assurance manager cv radiovkm.tk Sample Resume Objectives Quality Control Inspector Archives … quality control resume format – Keni.candlecomfortzone.com quality control inspector resume samples radiovkm.tk The results . Demonstrates strong organizational skills and ability to work independently, Current and unrestricted California Registered Nurse License required, CPHQ or transplant certification strongly preferred, Work in a matrixed environment to take our organization to the next level including test automation, continuous integration & deployment, and multi-platform test strategy optimization, Drive E2E strategy and planning for large software projects, Create the next generation strategy of testing frameworks, release techniques and infrastructure to increase the speed of release cycles and allow for constant high quality product, Build and manage a matrixed quality engineering team to meet the needs of products under development, Mentor junior members of the team in SDLC best practice and testing methodology in and Agile and Waterfall environment, Regularly collaborate outside of the immediate team to solve problems and share best practices, Collaborate with other teams to define project goals including scope, quality and timeframe, Creates flexible project plan, including requirement definition, task definition, talent assignment, capacity planning and timeframes. Actively participate in resolving quality issues. Knowledge of mobile development and testing a plus, Able to communicate effectively both verbally and in writing. Quality Assurance Manager Resume Examples. My resume is now one page long, not three. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. To be the successful job candidate for quality assurance jobs, it helps to have a comprehensive resume, says resume expert Kim Isaacs. Are you looking for Quality Assurance resume samples? Are you a Senior Quality Assurance by profession and looking for an exciting career? Shire expects all employees to live the BRAVE values, Drug Product Exception Reporting OOS, Trending, Aberrant Results, Manage technical transfer to CMO/contract lab to ensure they comply with regulations and Shire policies, Monitor QA activity to maintain and ensure job quality, Audit CMO/venders to ensure manufacturing and QC activity meet guidelines and regulations, Evaluate GMP protocol/report and report to stake holders, Periodically review all GMP/GQP SOPs and record to meet cGMP, Effectively manage and maintain Document Center, Provide and update QA documents (SOP, records etc), Implement staff training, pre-evaluation of CC, prepare GMP inspection, pre-review printing materials, self-audit, TQA update, take meeting minutes, Ensure that the Quality System is compliant with the relevant current medical device regulations in Canada, the United States, Europe, and Australia and compliant with the quality system requirements of the Corporation, Ensure that products have the required medical device premarket clearances and licenses to be sold in these markets, Provide subject matter expertise, interpretations and training on applicable medical device regulations, Minimum 5 years of experience in the medical devices, pharmaceutical or other life sciences industry, Working knowledge of medical device regulations in Canada, United States, Australia and European Union, Certified Quality Auditor, Certified Software Quality Engineer, or Certified Quality Manager recommended but not required, Regulatory Affairs Certification (R.A.C.) Interfaces with senior EP staff and offshore staff to provide and review assignments, provide and receive training on feature functionality and test development techniques, and participates in quality reviews of test plans and scripts, Can represent and advocate for EP with other members of the Product Development team for the purposes of joint triage of defects, reporting test results, and making overall product quality assessments, Communicates progress and escalates issues to management in a timely manner, Has independence and self-drive, creativity, and basic programming skills, Experience in developing test tools to improve productivity of test development and execution in a SaaS architecture, Write, monitor, execute and evaluate application tests using industry standard automated testing tools, Maintain automated test scripts to meet software release deliverables, project testing requirements and other quality assurance considerations, Create scripts to compare and validate data results from testing, Set up data, tools, and databases to support integrated test environments, Create and execute release and upgrade automation test plans, Mentor and assist members of QA staff with converting manual test plans to automated test scripts, Apply test methodology and product knowledge in the design of tests and testing strategies, Conduct root cause analysis of identified defects, providing sufficient details to understand, replicate and resolve the defect, Bachelors in Computer Science/Engineering or related field strongly preferred, Minimum of 7 years of experience in the software industry, Experience (minimum of 5 years) designing and developing automated test scenarios, Strong Test automation experience (minimum of 5 years) with at least two of the following tools: QTP, Selenium, TFS Test Automation, SoapUI, SilkTest, LoadRunner, NUnit and custom test tool, Experience with performance or load testing preferred, Experience with C# and API testing preferred, Experience with automated test data generation (red gate, etc.) Description needs to be impeccable comply with Division procurement procedures and meet quality standards by traveling vendor... 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