Quality Assurance Expert
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1. Conduct thorough reviews of batch documentation to ensure compliance with SOPs, GMPs, and regulatory requirements.
2. Verify production and analytical documentation accompanying the release of drug substance, drug product, and packaged finished goods to guarantee conformance to appropriate SOPs, GMP, and regulatory specifications, including supporting QP certification.
3. Maintain open communication and collaboration with functional areas to foster a strong working relationship and understanding of roles and responsibilities.
4. Utilize this network to resolve comments and issues that arise during audits and reviews.
5. Manage product recalls and stock recoveries as necessary.
6. Identify compliance gaps and suggest recommendations for continuous improvement.
7. Develop and maintain assigned standard operating procedures (SOPs).
8. Perform and review complaints and deviation investigations, change controls, and corrective actions.
9. Assist in the induction process for new starters and training of other staff members.
10. Ensure all assignments are completed to standards of compliance, efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements.
11. Stay up-to-date with current cGMP requirements as described in applicable worldwide regulations.
12. Represent the department on cross-functional teams.
13. Support the generation, review, and approval of technical and quality agreements.
14. Additional tasks as assigned by the supervisor or manager.
Required Skills and Qualifications
* Bachelor's degree in a quality, science, or engineering discipline, potentially supplemented by advanced degrees or extensive industrial experience.
* A minimum of 3 years of relevant post-degree experience in a GMP environment.