Senior QA Specialist (Pharmaceutical)

About our client : Our client is a leading global pharmaceutical company. About the role : • Support Singapore Operations facility start-up during commissioning, qualification, and validation of facilities for subsequent clinical and commercial manufacturing. • Support validation business processes across the campus, including process, facility, aseptic, and cleaning validation. • Work cross-functionally with Manufacturing, Engineering, QC, MS&T, and IT teams. • Guide execution and provide QA oversight during commissioning, qualification, and validation of manufacturing equipment, utilities, QC instruments, computerized systems, and facilities. • Support execution of core quality processes, ensuring timely and accurate documentation and data integrity. • Provide direct, on-the-floor QA oversight to ensure activities align with cGMP, approved procedures, and the site pharmaceutical quality system. • Review and approve qualification and validation deliverables, changes within the change management framework, deviation records, reports, and related documentation. • Advise on GxP expectations and actively participate in audits, inspections, and health authority interactions. • Identify, assess, and communicate quality risks, and ensure risks are appropriately managed. • Conduct independent analysis and provide insights on quality metrics and KPIs, translating trends into actions that improve compliance and reliability. • Deliver quality training and coach early-career team members on processes, systems, digital tools, and compliance. About you: • Bachelor's or Master's degree in a science or technical field such as Biotechnology, Pharmaceutical Sciences, Engineering, Biology, or Chemistry. • Minimum 10 years of validation experience working in a sizeable QA function within pharmaceutical or biopharmaceutical highly regulated manufacturing environments. • Strong understanding of cGMP requirements, regulatory trends, and Pharmaceutical Quality Systems. • Experience providing quality oversight within manufacturing/QC, validation, and related operations. • Excellent oral and written communication, collaboration, and stakeholder management skills, with proactive leadership and a strong quality mindset. • Ability to make sound, risk-based decisions in a fast-paced operational environment. • Strong negotiating and influencing skills, analytical and problem-solving skills, with the ability to manage complex quality issues. • Experience supporting investigations, deviation management, CAPAs, and risk assessments. • Ability to interpret regulatory requirements and apply them within operational settings. • Strong organizational skills with the ability to manage multiple priorities and changing business needs, with a desire to support manufacturing operations. • Experience across several areas, including biological, synthetic active pharmaceutical ingredients, sterile/aseptic, and biopharmaceutical manufacturing environments. • Experience with significant validation programs, including greenfield or brownfield projects. • Experience and knowledge of using digital pharmaceutical systems, data visualization platforms, or analytics solutions to improve quality outcomes. • Experience supporting digital, automation, or AI-enabled transformation initiatives within a GxP environment, with strong knowledge of the testing lifecycle. • Familiarity with process improvement methodologies such as Lean, Six Sigma, or operational excellence frameworks. Other: • Employment Type: Project-based contract role • Work Schedule: 5 days per week • Location: Tuas, Singapore *Please note that only shortlisted candidates will be contacted.* Employment Agency: Kingsforce Management Services Pte. Ltd. Employment Agency Licence No: 94C3545 EA Personnel: Kimberly Wong EA Personnel Reg. No.: R1984508