Top Pharmaceutical Firm Seeks Quality Assurance Expert.
Job Description:
* The selected candidate will be responsible for providing technical expertise, feedback, and guidance on QA and compliance matters.
Responsibilities:
1. Serve as the site QA point of contact to provide technical expertise, feedback, and guidance on QA and compliance matters, including validation strategies and manufacturing-related issues.
2. Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
3. Oversee QMS elements including deviations, change control, CAPA, internal/external audits, customer complaints, vendor management, and the review and approval of manufacturing batch records and production materials.
4. Generate, review, and approve SOPs and other documentation related to areas of responsibility.
5. Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
6. Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
7. Maintain documentation schedules to support technology transfers and new product introduction timelines.
8. Apply Quality Risk Management principles to all applicable activities.
9. Act as QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
10. Actively contribute to site-wide continuous improvement initiatives.