QA Site Supervisor I Pharma MNC I New Plant Start-up

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

QA Site Supervisor I Pharma MNC I New Plant Start-up

Job Openings QA Site Supervisor I Pharma MNC I New Plant Start-up

About the job QA Site Supervisor I Pharma MNC I New Plant Start-up

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

We regret that only shortlisted candidates will be notified.