Save Job Back to Search Job Description Summary Similar JobsOpportunities to work in a well-established company.Comprehensive benefits package.About Our ClientOur client is a notable player, with a strong presence in the industry.Job DescriptionOversee and maintain the company's Quality Management System (QMS) in compliance with cGMP, national and international regulatory requirements.Lead QA operations including batch release, in-process quality oversight, quality control support, and documentation management.Ensure effective handling of deviations, investigations, CAPA, risk assessments, and change control processes.Lead internal audits and manage external regulatory inspections (e.g., BPOM, FDA, EMA) and customer audits.Provide quality oversight for manufacturing, packaging, laboratory operations, and supply chain activities.Approve quality-related documents including SOPs, validation protocols/reports, and product quality reviews.Drive continuous improvement initiatives to enhance compliance, product robustness, and operational efficiency.Collaborate closely with production, engineering, regulatory affairs, and supply chain to ensure end-to-end quality alignment.Train, mentor, and develop the QA team to strengthen quality culture across the organization.Ensure timely and compliant batch disposition and release-to-market processes.The Successful ApplicantBachelor's degree or higher in Pharmacy, Chemistry, Chemical Engineering, or related scientific field.Minimum 8-12 years of experience in pharmaceutical manufacturing, with significant exposure to QA/QC, GMP compliance, and regulatory audits.Strong knowledge of GMP, GLP, GDocP, ICH guidelines, and relevant global regulatory requirements.Demonstrated experience leading quality audits, investigations, CAPA, and change control systems.Proven leadership capabilities with experience managing and developing QA teams.Strong analytical, problem‑solving, and decision‑making skills with high attention to detail.Excellent communication and stakeholder management skills, especially in cross‑functional environments.Ability to handle regulatory interactions and respond to inspections confidently and effectively.What's on OfferOpportunities to work in a well-established company.Comprehensive benefits package.ContactNatasya CrystalQuote job refJN-032026-6970797Phone number+62 21 2958 8822Job summaryFunctionEngineering & ManufacturingSub SectorQuality, TechnicalWhat is your area of specialisation?Healthcare / PharmaceuticalLocationJakartaContract TypePermanentConsultant nameNatasya CrystalConsultant contact+62 21 2958 8822Job ReferenceJN-032026-6970797
