SUMMARY
The Quality Assurance Manager (QA Manager) role sits within the Quality Department. It covers GMP/GDP-related quality management systems and related activities, including deviations, investigations, nonconformities, market complaints, change management, vendor management and the training process.
The QA manager monitors and optimizes the quality of processes and leads the QA department.
DUTIES & RESPONSIBILITIES
- Responsible for review, follow-up, periodic reconciliation, and tracking of necessary documentation related to deviations, investigations, non-conformities, change requests, self-inspection, external regulatory inspections/audits, and risk assessments;
- Responsible for providing support as needed to the auditing process: self-inspection/internal audit and regulatory audits;
- Contribute to the quality management review meetings through data gathering and data dashboard preparation;
- Ensure that training curricula and matrices are in place, training is completed and documented promptly, and training effectiveness is periodically evaluated;
- Ensure that changes in GMP/GDP-related legislation and guidelines are identified, assessed for impact, and implemented within the QMS in a timely and documented manner;
- Maintain up-to-date general GMP/GDP knowledge through periodic training and ensure the trainings of personnel are always up to date;
- Promote and monitor data integrity principles (ALCOA+) across GMP/GDP-relevant processes, including appropriate system access control, audit trail review, and periodic checks of critical records;
- Maintain up-to-date knowledge of company QMS and processes through training into the most up-to-date versions of the approved documents, and any other company policies as defined in the training requirements and applicable to each function within the company;
- Draft/review/approve SOPs;
- Act as process owner for the document control system, ensuring timely creation, review, approval, distribution, and archival of controlled documents;
- Support the GMP/GDP-related activities and the QP/RP disposition through a review of the incoming documentation.
QUALIFICATIONS
- A minimum of a BSc degree in Life Sciences, Pharmacy, or Business Administration (or an equivalent qualification).
- Proven experience with EU GDP regulations and compliance.
- Relevant GMP/GDP training as required to discharge assigned duties and responsibilities.
- Ability to work under stress and provide a non-biased, objective review of documentation, any QMS/Operational process.
- Enthusiastic and provides support to colleagues within the company, bringing new ideas and focused on continuous GMP/GDP improvement of processes and QMS;
- Fluency in written and spoken English is required. Knowledge of Dutch is preferred;
Salaris: €4.500,00 - €5.500,00 per maand
Arbeidsvoorwaarden:
- Bedrijfsopleiding
- Kosteloos parkeren
- Pensioen
- Telefoon van de zaak
- Werk vanuit huis
Werklocatie: Hybride werken in 1114 Duivendrecht
