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The QA Manager is responsible for activities related to Quality Management Systems (QMS), together with the QA team (5fte).He/she will present the quality system to external (governmental) auditors and lead the Hepac team, its management, outside vendors and contractors to deliver quality product. The QA Manager will report directly to the Plant Manager and will work in close collaboration with other companies within the Darling Ingredients Group. The responsibilities of the QA Manager
- Manage and coach the QA team.
- Develop, implement and maintain quality assurance programs, policies and procedures to ensure compliance with regulatory requirements such as FDA, EMA and other applicable regulatory bodies.
- Translate relevant pharmaceutical regulation into Hepac policies and the Hepac quality system. Applying a risk-based approach if needed. Takes initiative for external know-how if relevant.
- Establish and maintain a comprehensive quality management system to support the development, manufacturing, testing and distribution of crude Heparin.
- Awareness of changes in regulatory requirements and industry standards, ensuring that the company's quality systems and processes remain up-to-date and in compliance.
- Key spokesperson during audits presenting the Hepac quality organization and the quality system at every level. (e.g. sourcing, Burgum & Loenen production, contracted QC work).
- Authorizes Heparin product to be available for sales (ensures product quality is sufficient, Heparin is produced in adherence with the Hepac quality system and QC results obtained and meet requirements).
- Ensure the quality requirements are understood by Hepac co-workers and its contractors (e.g. training).
- Conduct regular audits of manufacturing facilities, laboratories and (raw material) suppliers to assess compliance with GMP (Good Manufacturing Practices) and other relevant regulations.
- Lead investigations into deviations, out-of-specification results and quality incidents, implementing corrective and preventive actions as necessary.
- Support process validation and equipment qualification (e.g. IQ, OQ, PQ protocols and reporting).
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