Senior Quality OfficerPreparation of QP batch release for Products (Quality records, Batch recordreview, release documentation), overall QMS compliance relating to QA Operational tasks. You play a key role in executing structured simple Root Cause Analyses (RCA), tracking CAPA effectiveness, and supporting audit readiness. Your work contributes to maintaining product quality, reducing recurring issues, and ensuring continuous process improvements within the organization.ResponsibilitiesBatch ReleaseBatch record reviewPreparation for QP batch release (intermediates, Drug Substances, DrugProducts and Finished Products)Supervise QA Officers (or junior personnel in general ) in Communication with OMCLPhysical release in the product WarehouseQMS Assessment and review, follow-up and timely closure of minor/major/(Critical if SME) deviationsAssist extended Root Cause Analyse (RCA) with known techniques.Assessment and review, follow-up and timely closure of OOS / OOL /OOT records.Assist Quality engineers in Investigation and timely closure of Product Quality ComplaintsHandling of returned goodsReview, follow-up and timely closure of Corrective and Preventive actions (CAPA’s)Execute deliveries from change controlsValidation support Review & Approval of routine Equipment validationsInspectionsSME (Subject Matter Expert) during Self inspection as auditee, and customer audit. Back office in regulatory audit. Support presentation of process in regulatory auditsTraining On the Job of QA Ops staff in Deviations, CAPA’s the related systemsCompliance reviewWriting of GMP-proceduresreview and approval of GMP-documents (e.g. GMP-procedures, master batch records)Documentation and reportingDeliver quality raw data for monthly Metrics and Quality Management Review and for Product Quality Review.QA on the shopfloorPerform shopfloor visitsPeople management/ leadership (example)Coach junior member team. Possible project leader if SME.Stakeholder Management (example)Support Quality lead in stakeholder managementGxPTakes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.Your Profile:Bachelor/ Academic (master’s degree) in Life Sciences/ PharmacyHBO > 2yrs experience or young Academic (MSc)Basic knowledge of the GMP-guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred.Experience with Trackwise/ Mastercontrol/ SAP or similar.Dutch and English speaking (work proficiency) English writing skills.You naturally take a proactive approach are an analytical thinker and clear communicatorWhat we offer:A market-rate salaryA budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthlyA fulltime employment of 40 hours per weekFlexible working hours after deliberationYour own place in a close-knit and expert team with an employer that stimulates growth and personal developmentGood accessibility by public transport and we provide private parking;Sound pension provision.

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