Freelance Quality Assurance Specialist (Yacht Life Sciences) (ZZP)

Job Description

Yacht Life Sciences has a vacancy for a Quality Assurance Specialist to work at Johnson & Johnson Innovative Medicine in Leiden. Your main tasks as a QA Specialist:The QA Specialist acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Planning, R&D etc.)The activities include, but are not limited to:

• Paper and electronic batch record review

• Raw material release

• Document revisions review and approval

• Review and approve analytical method transfer protocols and reports

• Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation depending on experience.

• Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.

• Depending on experience supporting master material changes

Job requirements

• BSc/HBO (or equivalent) or master’s degree in bioscience, biotechnology, biochemistry, pharmacy biomedicine, process technology

• >4 years of QA experience in pharmaceutical or related industry;

• Up-to-date knowledge of current GMP regulations;

• Experience in Change control and all documenting related activities;

• Experience with documentation systems like Trackwise, True Vault is preferable;