Senior QA Specialist (Pharmaceutical)
Must-have:QA/Test
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