Quality Manager - ref. t16236923
Synerfac Technical Staffing Malvern
Management & Organization
- Ensure a safe and healthy work environment. Get strong participation from the Quality team to HSE program. Monitor, verify, evaluate, and drive improvement towards site goals.
- Ensure staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed.
- Develop people capability & knowledge (technical expertise, behavioral & managerial).
- Ensure communication of the quality objectives and priorities to all site personnel.
- Manage resources according to quality objectives, site priorities & anticipate future business needs including headcount and finances.
- Actively recruit, coach, and develop personnel within the quality unit.
- Ensure that Quality activities are performed in accordance with procedural requirements and meet planned timelines.
- Provide administrative support & technical leadership to the site quality unit.
- Assures the independence of the Site Quality Unit.
- Ensures the development, adequacy, and effectiveness of the site"s quality management system.
- Ensures systems are in place to release or reject raw materials, intermediates, packaging materials, components, and consumables.
- Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
- Ensure all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
- Ensure a system is in place for approving specification, sampling instructions, test methods & batch records.
- Ensure that all required quality agreements are in place & maintained.
- Ensure site processes, equipment, instruments, utilities & facilities are qualified / validated and maintained for the intended use.
- Participate in approving Annual Product Reviews.
- Ensure site audit & inspection readiness. Host audit & inspection. Assure timely closure of all regulatory commitments.
- Assure the adequacy & effectiveness of the site quality systems.
- Participate on the Site Lead Team and lead the Quality Lead Team.
- Ensure overall compliance with GMP regulations
- Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
- Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).
- Participate in project evolution and customer meetings.
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