Quality Manager

apartmentSynerfac Technical Staffing placeMalvern calendar_month 
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.
Quality Compliance
  • 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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