Quality Assurance Specialist
/ Officer (API & Manufacturing) About Our Client
- Location in Tuas
Our client is a leading global biopharmaceutical multinational corporation (MNC) with a well-established manufacturing presence in Singapore. They are seeking a meticulous and driven Quality Assurance Specialist to join their Quality team in driving cGMP compliance, batch disposition, and quality system oversight. Key Responsibilities Batch Record Review & Disposition: Review and approve master and completed batch records for the manufacturing, packaging, and labeling of active pharmaceutical ingredients (APIs) and intermediates, ensuring compliance with internal quality standards and regulatory specifications. Perform disposition of intermediates and APIs.
Documentation & Standards: Review and approve cleaning instructions, cleaning records, SOPs, protocols, reports, and change controls in accordance with ICH guidelines and site document standards.
cGMP & Compliance: Ensure all operational and quality activities align strictly with current Good Manufacturing Practices (cGMP) and regulatory requirements.
Deviation & Investigation Management: Review and approve deviations, investigation reports, root cause analyses (RCA), and Corrective/Preventive Actions (CAPA). Collaborate with Subject Matter Experts (SMEs) to assess quality, validation, stability, and regulatory impacts.
Inspection Readiness & Audits: Support site inspection readiness, participate in routine GMP facility walkdowns, and assist during internal, regulatory, and customer audits.
Quality Metrics & Trend Analysis: Maintain quality tracking systems, support the preparation of Annual Product Reviews (APR), evaluate trend data, and recommend proactive improvement actions.
Cross-Functional Collaboration: Actively participate in assigned Value Stream Teams (VST) to report performance metrics, resolve quality issues, and support continuous improvement initiatives.
Safety & EHS: Participate in safety initiatives and support Environmental, Health, and Safety (EHS) investigations when required.
Minimum Requirements Education & Experience: Diploma in Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or a related field with at least 4 years of relevant quality assurance experience, OR
Bachelor’s Degree (B.S. / B.A.) in a relevant scientific field with at least 1 year of relevant experience.
Industry Knowledge: Hands-on experience in the pharmaceutical/API manufacturing industry and familiarity with Quality Management Systems (QMS).
Regulatory Understanding: Solid knowledge of cGMP standards and ICH guidelines.
Communication: Strong written and verbal communication skills with the ability to collaborate effectively across interdepartmental teams.
Preferred Qualifications / Good-to-Have Direct Quality Assurance experience within a pharmaceutical manufacturing plant environment.
Proven track record in writing, managing, and investigating deviations, non-conformances, and executing change controls.
Familiarity with Enterprise Resource Planning (ERP) systems and electronic quality management software.
Excellent problem-solving, time management, and multitasking capabilities.
Familiarity with common AI and digital productivity tools (e.g., Microsoft Copilot) to enhance workflow efficiency and problem-solving.