This position is responsible for providing support and expertise to the different departments of the Center For Secondary Packaging (CSP) in the area of quality and GMP compliance to ensure that all pharmaceutical products, equipment, facilities & utilities, lab methods and computerized systems are validated in compliance with current GMP regulations and PQS requirements.
- Ensuring that all pharmaceutical equipment, facilities & utilities, lab equipment and computerized systems are validated in compliance with current GMP regulation and PQS through:
- Participate as quality authority in impact assessments, quality risk management and determination of validation strategy for projects and during change management
- Review and approval of validation, quality risk management and change control documentation.
- Participate as specialized project team member in capital projects, assisting in, and reviewing of the Validation Project Plan and ensure the alignment with the capital project planning.
- Represent QA in departmental and inter-departmental meetings.
- Depending on the individual situation, the QO engineer is accountable for several of the items below:
- Ownership of quality systems and SOPs (Change Control, Validation, Quality Risk Management), to ensure the process is efficient, effective and compliant.
- Design the process and define roles and responsibilities
- Act as a quality system contact person during regulatory inspections
- Managing routine and complex continuous improvement projects and corrective and preventive actions for these quality systems.
- Create and provide training of all users of the systems
- Leading or participating in interdepartmental systems teams that work on maintenance and improvement of these quality systems
- Knowledge management of requirements, best practices and interdepartmental alignment.
- Develop experience in specific validation areas, and act as a point of contact for those areas. Knowledge management of requirements, best practices and interdepartmental alignment for these areas.
EDUCATION AND EXPERIENCE
- Master Degree in a Scientific discipline (Pharmacy, Engineering, Bio-Engineering,...)
- Experience required in Validation/Verification/testing/quality systems knowledge
- Experience with at least one specific relevant validation area (preferably production equipment, but can also be HVAC, Lab Equipment, Software, etc.)
- Quality mindset
- Good analytical and problem solving skills
- Good social and communication skills (active listening, assertiveness, negotiating, team player, ...)
- Capable to maintain an 'helicopter view" while diving into details when needed. Able to set priorities.
- Work efficiently with people of different backgrounds to gain acceptance on GMP issues
- Fluency in Dutch and English