About the RoleProthya Biosolutions is currently seeking a motivated and detail-oriented Senior QA Officer QMS to join our Quality Assurance team. In this role, you will play a key part in ensuring GMP compliance, supporting QP batch release activities, and maintaining high-quality standards across manufacturing operations.You will work closely with cross-functional teams including Manufacturing, Quality Control, Engineering, and Regulatory Affairs to ensure compliance, continuous improvement, and operational excellence.Key ResponsibilitiesGMP & Batch Release ActivitiesPreparation of QP batch release documentation for intermediates, Drug Substances, Drug Products, and Finished ProductsBatch record review and approvalPhysical release of products in the warehouseEnsure overall QMS compliance related to QA operational tasksSupervise QA Officers or junior personnel where applicableCommunicate with OMCL where requiredQuality Management System (QMS)Assessment, review, and timely closure of deviations (minor, major, critical where applicable)Support extended Root Cause Analysis (RCA) using established methodologiesReview and closure of OOS, OOL, and OOT investigationsSupport investigations related to Product Quality ComplaintsHandling of returned goodsReview and follow-up of CAPAsExecute and follow up on change controlsValidation SupportReview and approval of routine equipment validationsSupport validation activities where requiredInspections & AuditsAct as Subject Matter Expert (SME) during internal audits and customer inspectionsSupport regulatory audits and inspection readinessPresent processes during audits where requiredTraining & ComplianceProvide on-the-job training to QA Operations staffSupport training in deviations, CAPA, and quality systemsWrite and review GMP proceduresReview and approve GMP documentation (e.g., SOPs, Master Batch Records)Documentation & ReportingDeliver quality data for monthly metrics and Quality Management ReviewSupport Product Quality Review documentationPerform routine shopfloor QA oversight visitsPeople & Stakeholder ManagementCoach junior team membersAct as project lead where applicable (SME)Support Quality Lead in stakeholder managementRequirementsBachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fieldExperience in GMP-regulated pharmaceutical or biotechnology environmentExperience in QA Operations, Batch Release, or Quality Systems preferredKnowledge of EU GMP guidelinesStrong analytical and problem-solving skillsExperience with deviation management and CAPA processesStrong communication and stakeholder management skillsDetail-oriented with strong documentation skillsAbility to work independently and within cross-functional teamsWhat We Offer8.33% end-of-year bonus and 8.33% holiday allowance.A personal training budget of €2,100 every three years to foster professional growth and development.Contribution to travel expenses from the first kilometer.Excellent accessibility by public transport and private parking available.A pension plan with Zorg & Welzijn, providing security for your future.A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

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Senior Quality Officer QMS