For a client in the region of Puurs/Bornem, we are looking for a QO Engineer.
Important for this opportunity;
- A first experience in Validation
- A scientific master degree
- Good knowledge of Dutch and English
- Coaching skills
Do you possess these characteristics? Then you are the candidate we are looking for!
Don't hesitate to contact me and send me your resume.
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.
- 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.
- 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. Able to set priorities.
- Good social and communication skills, Fluency in Dutch and English.
- Capable to maintain an ‘helicopter view” while diving into details when needed. Work efficiently with people of different backgrounds to gain acceptance on GMP issues
Anneleen De Vos
015 21 11 04