QA Site Lead — GMP, Audits & Cleaning Validation

Recruit Express Pte Ltd.

Singapore

On-site

SGD 120,000 - 180,000

Full time

6 days ago

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Job summary

Recruit Express Pte Ltd. in Singapore seeks a QA Site Manager (Must Have API QA Exp) to lead on-site quality assurance across manufacturing, packaging, and warehouse areas. You will supervise QA staff, ensure GMP compliance, and drive improvements in the Quality Management System.

The role requires extensive experience with API QA, cleaning validation, material release, and regulatory interactions. Strong leadership and communication skills are essential to coordinate audits and maintain data

Qualifications

Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, or related discipline.
Minimum 5 years of relevant experience in pharmaceutical QA, manufacturing quality, or validation.
At least 2 years of supervisory or people-management experience in QA.
Strong knowledge of GMP requirements (Singapore HSA, PIC/S, EU, FDA) and QMS.
Experience in cleaning validation, deviations, CAPA, and data integrity.

Responsibilities

Lead on-site QA activities to ensure GMP compliance across manufacturing, packaging, and warehouse areas.
Oversee material release, line clearance, and related documentation control.
Develop and maintain cleaning validation programs and related QA systems.
Manage deviations, change controls, CAPA, and quality risk assessments.
Support customer audits, regulatory inspections, and internal audits with scientifically justified responses.