QA Manager

Candidate Profile
An ideal candidate is a driven and structured QA professional with strong GMP/regulatory expertise, audit & CAPA leadership, and pharmacovigilance management skills. Must have strong leadership, documentation rigor, communication skills, fluency in English, proactivity, and ability to coach teams and represent the company in regulatory inspections.

Key Tasks

1. Quality Leadership, Compliance & Batch Release – Monitor and improve QA systems, ensure compliance (GMP, BPOM, FDA, EU GMP, WHO), approve/release batches, lead CAPA & change control.

2. Audit, Inspection & Risk Management – Lead internal audits/self-inspection, support external audits (suppliers, BPOM, customers), manage findings, drive risk mitigation.

3. Validation, Documentation & QA Systems – Oversee validation programs, SOPs, deviations, NCRs, change control, and batch record review.

4. Pharmacovigilance – Manage pharmacovigilance implementation per BPOM regulation at the factory.

Traits Required: Driven, Structured, Responsible

Key Challenges

• Maintaining strict GMP & multi-agency compliance (BPOM, ISO, FDA/EU GMP)

• Leading root cause investigations & CAPA under tight timelines

• Coordinating multiple audits and timely close-outs

• Managing pharmacovigilance implementation

Skills

• Communication & interpersonal

• Documentation & record keeping

• Analytical & technical

• Leadership & project management

• Audit, compliance, problem solving, organization, time management

Knowledge

• GMP regulations (FDA, EU GMP, WHO)

• International & local regulatory requirements (FDA, EMA, TGA)

• Validation protocols (process, cleaning, equipment)

• Dosage forms & production techniques

• Chemical & microbiological testing (HPLC, GC, UV, IR, microbiology)

• Deviation, RCA & CAPA management

• Internal & external audits

• Environmental monitoring (air, water, particle count)

• Pharmacovigilance & Product Lifecycle Management

• EHS, ISO 9001, Halal Product Assurance

Other Parameters

• Education: Bachelor in Pharmacy, Registered Pharmacist (Pharmacovigilance training preferred)

• Experience: 8–12 years in QA (pharma/healthcare manufacturing)

• Current Role: QA Supervisor/Assistant Manager/QA Section Head/Senior QA Executive

• Preferred Companies: Multinational Pharma, FMCG (with GMP), Healthcare, strong QA system firms

• Reporting to: GM Manufacturing

HOW TO APPLY: Please send your CV to the consultant in charge: 
Mr. Aser Tomasoa
Email: aser.tomasoa@ev-search.com
All applications will be considered without regard to race, color, religion, sex (inclusing pregnancy and fender identity), national origion, political affiliation, sexual orientation, mariatal status, disability, genetic information, age, membership in an employee organization, parental status, military service or other nonmerit factor