Join our client with this QA position and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.
Proclinical is seeking a Senior QA Specialist (CMO Oversight) to support QA vendor oversight activities, ensuring compliance with cGMP standards and quality systems. This role involves managing contractor relationships, reviewing quality documentation, and overseeing product quality processes for commercial bulk and finished drug products. Occasional travel may be required.
Responsibilities:
1. Manage contractor quality assurance activities to ensure compliance with regulatory and corporate requirements.
2. Build and maintain strong working relationships with contractors.
3. Lead discussions on quality-related topics such as complaints, change control, deviations, and documentation.
4. Recommend and oversee quality-related improvements at contractor sites.
5. Review batch records, including master production-packaging records and executed batch records, for GMP compliance.
6. Manage and monitor change control requests, including evaluation, approval, and progress tracking.
7. Support and approve complaint investigations related to external vendors.
8. Review, edit, and approve contractor documentation, including validation protocols, reports, and investigations.
9. Lead the review of Annual Product Quality Review reports and negotiate improvements with contractors.
10. Draft, review, and recommend approval for Quality Agreements.
11. Participate in self-inspections and external audits of contractors as assigned.
12. Maintain logs, databases, and files related to product quality activities.
13. Perform trend reviews and compile metrics.
14. Develop and maintain pharmaceutical quality systems, author or revise SOPs, and provide recommendations on policies and standards.
15. Support GMP/GDP site inspections and ensure compliance with personal training requirements.
Key Skills and Requirements:
16. Strong knowledge of cGMP/GDP regulations for the USA, EU, and international markets.
17. Ability to balance business targets with scientific and quality decisions.
18. Excellent analytical, problem-solving, and project management skills.
19. Strong communication and organizational abilities.
20. Experience in developing and executing pharmaceutical quality systems.
21. Proficiency in computer systems.
22. Degree in a scientific discipline (BSc or equivalent).
23. Technical expertise in chemical, biological, and/or pharmaceutical operations.
24. Experience interacting with Health Authorities (e.g., FDA, EMA) and supporting inspections.
25. Proven ability to manage quality at external manufacturing sites.