Are you ready for your next QA challenge in the pharmaceutical industry? We have a new opportunity for managing varied projects ranging from change control management systems, to review the QMS documents. Apply today !
Responsabilities:
- Maintain oversight and control of equipment status at the company sites as well as at the point-of-care manufacturing partners' sites.
- Work in collaboration with QC teams to ensure oversight of equipment lifecycle including equipment qualification, maintenance and digital system deployment/updates.
- Material quality oversight including supply chain management, material qualifications, material specifications and incoming goods disposition.
- Reviewing and approving QMS records (deviations, change controls, CAPAs).
- Reviewing and approving QMS documents throughout the lifecycle and new process deployment.
- Quality assurance point of contact for systems implementations for QC Cell Tech Operation.
- Reviewing and approving QMS QC methods and method transfer documents.
Working Relationships:
- Quality Control (QC technician, QC analyst and QC managers of operations).
- Quality Assurance (QA Point-of-Care, QP)
- Manufacturing (Packaging of starting materials)
- Supply chain (incoming goods, materials qualification, vendor qualification)
Requirements:
- Master of Science in life science or related Quality management field.
- Over 3 years experience in GMP environment.
- Hands-on experience in QMS records/documents handling.
- Fluency in English and Dutch (documents in both languages)
- Meticulous and detail-oriented.
- Excellent communication and writing skills.
- Existing right to work in Europe required
Benefits
- Part time : 0.8 FTE
- Location : Leiden, on site 3 days/week and 2 days remote
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
