Senior Manager QA/RA Projects Lead
vor 2 Monaten
This position is a safeguard and role model for the WuXi values and competencies, ensuring the entire Couvet site adheres to the Marketing Authorisation Dossier managed by the Customer/Product Owner and supports the site in Company Regulatory Surveillance initiatives.
Key Responsibilities- Act as the deputy of the Responsible Person (RP) according to Art. 5, and Art. 17 of the Swiss Ordinance on Establishment Licenses (SR and of the Qualified Person according to Annex 16 of the EU Guide to Good Manufacturing Practice for Couvet site.
- Act within the site's key projects teams as the main Quality representative and single point of contact for QA, Compliance, Quality Supplier, and Regulatory Affairs.
- Act as the point of contact with customer for quality topics, coordinates response/notification to the client related to quality topics.
- Coordinate and drive quality activities related to technology transfer, analytical tech transfer, raw materials introduction, supplier qualification, manufacturing specifications, and CMC dossier set up.
- Conduct assessment of change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs and act as the site interface with Global Regulatory (CMC & Affairs).
- Support response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review, as well as review of regulatory authorities citation provided to other sites.
- Actively support site Quality activities such as multi-sites investigations, drive change controls upon requests, review of MBR and executed batch record related to NPI, internal audits (as auditor), health authority and client inspections, and continuous improvement.
- Ensure compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility.
- Works closely with EHS to evaluate hazards and perform risk analysis.
- Promotes safe practices and behaviors, verify that EHS rules are implemented and followed.
- Release of batches as RP deputy.
- Close out of Critical Complaints.
- Approval of Complaints Extension Requests when an escalated approval is required.
- Approval of Investigation Reports/Notifications sent to Health Authorities related to Complaints.
- Approval of Master Batch records.
- Approval of documentations related to Suppliers/CSPs qualification and maintenance activities.
- APR/PQR approval.
- At least 7 years of experience in Quality Assurance, Quality Control, and/or Regulatory Affair in a pharmaceutical company or other related industry.
- Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Demonstrated experience in Regulatory strategies and tactics.
- Strong knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
- Solid understanding of Oral Solid Dosage form manufacturing, packaging, testing, warehousing processes, validation, and registration.
- Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.
- Excellent interpersonal, collaborative and organizational skills.
- Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.
- High credibility and reliability.
- Excellent investigational and QA problem solving skills.
- Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.
- Drives continuous improvement.
- Knowledge of most common office software and of IT-principles.
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Senior Manager QA/RA Projects Lead
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