QA Document Control Specialist

il y a 2 jours


Belgium Panda International Temps plein

Are you detail-oriented and passionate about quality documentation within a GMP environment? As a Quality Assurance Document Control Specialist at a leading Biopharma cell therapy manufacturer, you will play a critical role in ensuring document compliance across clinical and commercial manufacturing operations.This role offers exposure to electronic quality systems, batch documentation, SOP management, and archival processes within a sterile GMP environment. It is an excellent opportunity for candidates starting or developing their career in Quality Assurance within the biopharmaceutical industry.Must Have RequirementsUndergraduate, secondary degree, or equivalent professional experienceKnowledge of GxP regulations (EU GMP/GDP, 21 CFR, ICH Q10, Annex 11 / Part 11, PIC/S, MHRA)Operational experience with electronic quality systemsExperience with document control or document management processesProficiency in Microsoft Outlook, Excel, Word, and PowerPointFluency in Dutch and technical EnglishAbility to work in compliance with cGMP and quality system requirementsDesirable RequirementsExperience working in a GMP manufacturing environmentExperience with Document Management Systems such as Veeva or TruVaultExperience with batch documentation issuance and reconciliationExperience with SOP review and approval workflowsExperience in biopharmaceutical, biotech, or cell therapy manufacturing environmentsExperience supporting clinical and/or commercial manufacturing operationsResponsibilitiesManage site document control systems and processesReview and approve SOPs and controlled documentsSupport document management system users and workflowsManage periodic review of GMP documentationIssue and reconcile batch-related documentationCreate and issue GMP logbooksEnsure storage, archival, and retention of GMP recordsReconcile documentation in line with document lifecycle requirementsSupport continuous improvement initiativesEnsure compliance with safety policies, quality systems, and cGMP standardsWhat We OfferMeaningful QA role within advanced cell therapy manufacturing4 days on-site followed by 4 days remote work patternSupportive and innovative working environmentExposure to international and multicultural teamsInterim contract with permanent opportunity after 6 monthsAttractive salary package with benefits including meal vouchers, insurance, bonuses, and additional vacation daysInterested in Learning More?If you would like to explore this opportunity confidentially, feel free to contact:Maurits van Sloun m.vansloun@panda-int.com


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