Quality Assurance Specialist

The CompanyA global pharmaceutical and medical device organisation recognised for its commitment to quality, compliance, and innovation. Operating under strict GMP regulations, the company supports advanced manufacturing and validation processes.About the RoleWe are seeking a QA Validation Specialist to provide quality oversight for equipment validation, packaging qualification, and PASX master data management. This role ensures compliance with corporate, site, and regulatory standards while supporting change control and deviation management processes. It involves managing multiple smaller projects, acting as the QA contact for technical changes, and collaborating closely with cross-functional teams.Key ResponsibilitiesReview and approve equipment validation documentation and packaging qualifications.Act as QA contact for change controls and documentation review (engineering, validation, software qualification).Oversee PASX master data entries and ensure accuracy.Guide validation strategies in collaboration with PD, M&E, and IS teams.Approve equipment changes and parameter updates.Manage minor deviations and provide QA oversight for investigations.Perform final QA review of technical change controls and deviation records.Support ad hoc requests and engage in team activities.Your ProfileEducation: MBO or Bachelor’s degree in Life Sciences or Engineering (biomedical engineering is a strong example).Experience: Open to highly motivated graduates with strong analytical skills.Preferred: 3+ years in pharmaceutical or medical device industry.Skills: Analytical thinking, critical questioning, clear communication, attention to detail, curiosity, and adaptability.Technical:Knowledge of GMP, equipment and automation validation.Familiarity with computer compliance (Annex 11, Part 11).Experience with computer system validation and quality risk management is a plus.Systems: Awareness of Annex XI required; PASX and MES knowledge is a plus.Industry: Pharmaceutical experience preferred; other like food, aviation, or chemicals is considered if familiar with heavy documentation and regulation.Work ArrangementOn-site presence required at least 3 days per week (more is better for integration and training).Flexible schedule, but availability needed for qualifications and documentation sign-off.Full-time preferred (40 hours)ChallengesBroad scope and intensive training period (6–9 months to reach full proficiency).High documentation and regulatory workload.Requires patience, adaptability, and commitment to a long-term role.Other InformationCross-functional collaboration with PD, M&E, IS, and other QA teams.