QA Site Supervisor I Pharma MNC I New Plant Start-up
The GMP Group · Singapore ·
- Category
- QA
- Experience
- 2+ years
Leads day-to-day site QA for a new pharmaceutical manufacturing plant in Singapore, supervising QA specialists and ensuring GMP/QMS compliance across manufacturing, packaging and warehouse operations, with a focus on cleaning validation, material release, deviations/CAPA, and audits or regulatory inspections.
About the role
We are looking for an experienced Site QA Supervisor to support the Quality function of a new pharmaceutical manufacturing facility. The successful candidate will lead day-to-day Site QA activities across manufacturing, packaging, warehouse and supporting areas, ensuring compliance with GMP, Quality Management System (QMS) and regulatory requirements. This role will also supervise the Site QA team and play a key role in cleaning validation, material release, deviation/CAPA management, audits and regulatory inspections.
Key responsibilities
- Lead and supervise daily Site QA and shopfloor quality oversight activities.
- Ensure manufacturing, packaging, warehouse and supporting operations comply with GMP and QMS requirements.
- Perform GMP walkthroughs, inspections, internal audits and quality risk assessments.
- Provide QA oversight for line clearance, material status, documentation, data integrity and manufacturing activities.
- Review and approve documentation for raw material and packaging material release.
- Establish, maintain and continuously improve the site's Cleaning Validation Program.
- Lead or support investigations involving deviations, change controls, CAPA and quality issues.
- Support and coordinate customer audits, HSA/regulatory inspections, third-party audits and internal audits.
- Work closely with Manufacturing, QC, Warehouse, Engineering and Validation teams to resolve quality issues.
- Supervise, coach and develop Site QA Specialists and support continuous improvement of the Quality Management System.
About you
- Bachelor's Degree in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Chemistry, Biotechnology, Quality Management or related discipline.
- Minimum 5 years of relevant pharmaceutical QA / manufacturing quality / validation experience.
- At least 2 years of supervisory or team leadership experience within QA or Quality.
- Strong hands-on experience in Cleaning Validation within a pharmaceutical manufacturing environment.
- Good knowledge of GMP, deviation, CAPA, change control, quality risk management and data integrity.
- Experience in shopfloor QA oversight, material release and warehouse quality management.
- Familiarity with HSA / PIC/S GMP requirements; exposure to EU GMP, FDA cGMP or WHO GMP will be advantageous.
- Strong communication, leadership and stakeholder management skills.
- Able to work effectively in a fast-paced pharmaceutical manufacturing and new plant start-up environment.
About us
GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Dianna| Registration No: R1327268
For a faster process, please include your availability, current salary, and expected salary in your resume and submit to [email protected]
We regret that only shortlisted candidates will be notified.