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Quality Assurance Manager
4 weeks ago
Job Description
- Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
- Responsible for setting strategy direction for the Quality Assurance Dept. and team
- Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support if any
- Support team by guidance and coaching and provide direction/approval of activities and decisions
- Cultivate and reinforce appropriate group values, ethics, norms, and behaviors
- Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews
- Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls including SOPs and master batch records
- Conduct impact assess to design changes and participate/coordinate CAPA Review Board
- Maintain the structure to ensure that all quality commitments and timelines are tracked and met.
- Work directly with internal and external customers to assure Best-in-Class expectations for quality are met if not exceeded
- Analyze trends, quality metrics and other data to identify quality and compliance gaps
- Participates in the recruitment, selection, promotion, and performance management of QA employees.
Requirements
- Candidates should possess B.Sc Degrees with 2+ years relevant work experience.
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