Description
The QA Compliance Officer is responsible for ensuring adherence to current and pending EU GMP and US FDA requirements, maintaining compliance with regulatory standards, and supporting quality assurance activities. The role requires excellent verbal and written communication skills and the ability to work collaboratively within a team environment.
Key Responsibilities
1. Conduct routine quality audits of the facility to ensure compliance and proactively resolve arising issues.
2. Establish and maintain the internal audit schedule, ensuring its completion as planned.
3. Prepare and conduct the annual GMP training program for the site.
4. Approve compliance documents such as Deviations, SCARs, and CAPAs.
5. Conduct external audits, compile audit reports, and lead response collation.
6. Manage and assist with the site change control system.
7. Handle customer complaints efficiently.
8. Provide technical support to the MAH for new product introductions and existing products.
9. Review and lead process investigations, ensuring appropriate documentation and corrective actions where necessary.
10. Ensure process transfers are documented and conducted in accordance with regulatory standards.
11. Conduct quality reviews and approve RMWOs & RPWOs for Chanelle.
12. Update quality procedures in response to validation issues in cooperation with relevant departments.
13. Contribute to continuous improvement of the company’s quality system and GMP compliance.
14. Maintain records for company KPIs in line with quality management review requirements.
15. Provide timely feedback on customer and production queries.
16. Prepare product quality review reports for Chanelle.
17. Assist in troubleshooting product-related issues.
18. Perform finished goods inspections for all manufactured and packaged products before release and shipment.
19. Conduct GMP walks as required.
20. Assist with QA review and approval of executed Manufacturing, Filling, and Packaging Work Orders in preparation for QP release.
21. Prepare Certificates of Analysis for QP release.
22. Undertake any other duties assigned by the QA Manager or Head of Quality.
Qualifications
1. Bachelor’s degree in a science-based discipline.
2. Minimum of 1-3 years’ experience in a pharmaceutical manufacturing environment.
3. Working knowledge of EU GMP and US FDA guidelines.
Skills And Competencies
1. Ability to take direction and ask questions as needed.
2. Strong teamwork and collaboration skills.
3. Proactive development of technical skills.
4. Methodical, systematic, and structured approach to organizing work.
5. Ability to prioritize decision-making, differentiating between urgent and non-urgent matters.
6. Ability to escalate issues appropriately.
7. Willingness to help others and contribute to a positive team environment.
8. Displays flexibility and a willingness to learn and go the extra mile.
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