QA Site Lead – GMP & New Plant Startup

GMP Technologies; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

GMP Technologies (S) Pte Ltd is seeking 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, 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

Qualifications

• Bachelor's degree in Pharmacy or related discipline.
• Minimum 5 years of pharmaceutical QA/manufacturing quality/validation experience.
• At least 2 years of supervisory or team leadership experience within QA.
• Strong hands-on experience in Cleaning Validation within pharma manufacturing.
• 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 advantageous.

Responsibilities

• Lead and supervise daily Site QA and shopfloor quality oversight activities.
• Ensure operations comply with GMP and QMS requirements.
• Perform GMP walkthroughs, inspections, internal audits and risk assessments.
• Provide QA oversight for line clearance, material status, documentation and data integrity.
• Review and approve documentation for raw material and packaging material release.
• Establish and improve the site's Cleaning Validation Program.
• Lead or support investigations involving deviations, CAPA and quality issues.
• Support and coordinate customer audits, regulatory inspections and third-party audits.
• Collaborate with Manufacturing, QC, Warehouse, Engineering and Validation teams.
• Supervise and develop Site QA Specialists; drive continuous improvement of QMS.

Skills

GMP knowledge

Quality management

Leadership

Data integrity

Audits

Regulatory inspections

Education

Bachelor's Degree in Pharmacy/Pharmaceutical Science

Tools

Cleaning Validation

CAPA systems

Change control

Job description

GMP Technologies (S) Pte Ltd is seeking 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, 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