Quality Control Manager

7 dagen geleden

Leiden, Zuid-Holland, Nederland HAL Allergy Group Voltijd

Job Summary:

The HAL Allergy Group is seeking a highly skilled and experienced Quality Control Manager to join our team. As a key member of our organization, you will be responsible for establishing, maintaining, and enhancing processes within the Quality Control department in compliance with current Good Manufacturing Practice (GMP) regulations.

Key Responsibilities:

  • Manage the Quality Control department, coordinating daily activities, setting priorities, and ensuring effective daily operations to ensure timely reporting of analyses, timely completion of quality records, and timely execution and reporting of stability studies.
  • Accountable for personnel management within QC, including ensuring sufficient qualified personnel for the activities to be performed, setting performance objectives, employee performance evaluations, recruitment, disciplinary actions, and other personnel actions in collaboration with Human Resources.
  • Ensure high-quality work is performed by the Quality Control department and make sure that processes are compliant with company- and department Standard Operating Procedures (SOPs) as well as with applicable laws and regulatory guidelines.
  • Coordinate and oversee the set-up and execution of relevant training, implementation of procedures, deviation- and trend analyses, and the implementation of changes.
  • Ensure the safety of assigned areas and work practices in accordance with plant and company Environmental, Safety, and Health (ESH) programs.
  • Oversee and coordinate the preparation of specifications, sampling instructions, test methods, and other required Quality Control related procedures in collaboration with Analytical Development.
  • Responsible for the Laboratory Information Management System (LIMS) and keeping the system up to date and compliant with relevant regulatory laws and regulations.
  • Accountable for business continuity as owner of the test methods, equipment, and systems used.
  • Ensuring all methods, equipment, and systems used are in a validated state and that business continuity is guaranteed (e.g., by means of back-up systems or outsourcing options).
  • Accountable for all Quality Control activities that are outsourced to external contract labs.
  • Drive continuous improvement through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability, with the aim of reducing the number of deviations, incidents, and near-misses, increasing right-first-time performance, and shortening leadtimes.
  • Ensuring permanent inspection readiness within the Quality Control labs, carrying out self-inspections for both quality and safety, and providing timely follow-up to audit observations.
  • Identify all required Quality Control expenditures and ensure that Quality Control assays and projects are executed within time and budget.

Requirements:

  • Master's Degree in Biochemistry, Biotechnology, Molecular Biology, or similar.
  • Extended experience with and deep knowledge of microbiological-, biochemical-, and analytical chemistry assays and technologies.
  • 5-8 years relevant working experience in a similar management position.
  • Solid understanding and knowledge of applicable regulatory requirements and GMP quality directives is critical.
  • Audit/inspection experience.
  • Good command of the Dutch and English language, both verbally and in writing.

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