Quality Assurance Specialist (Pharmacist)

ALPHA MANPOWER PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A reputable logistics firm in Singapore is looking for a Quality Assurance Specialist (Pharmacist) to enhance their Quality Management System. The successful candidate will ensure compliance with Good Distribution Practices (GDP) and manage deviation and change control processes. Applicants must be registered pharmacists in Singapore with 3–6 years of QA experience in GDP environments. This role offers a competitive package and the opportunity to contribute to patient safety in the pharmaceutical industry.

Benefits

Collaborative culture

Ongoing professional development

Competitive package and benefits

Qualifications

• Must be a Registered Pharmacist with a valid Practising Certificate.
• 3–6 years of QA/QMS experience in GDP environments.
• Knowledge of HSA requirements and CAPA management.

Responsibilities

• Implement and maintain QMS aligned with GDP and client agreements.
• Lead internal audits and ensure compliance during client audits.
• Develop and deliver GDP training for stakeholders.

Skills

GDP Compliance

Root Cause Analysis

Quality Management System (QMS)

Stakeholder Management

Technical Communication

Education

Registered Pharmacist with Singapore Pharmacy Council

Tools

QMS/eQMS tools (e.g., Veeva, TrackWise)

Temperature Monitoring Systems

Job description

Quality Assurance Specialist (Pharmacist)

Location: Northeast, Singapore
Employment Type: Full-time
Industry: 3PL

About the Role

Our client is a temperature-controlled 3PL supporting global pharmaceutical and biotech companies. We are seeking a Quality Assurance Specialist who is a Registered Pharmacist in Singapore to strengthen our Quality Management System (QMS) and drive GDP compliance across warehouse and distribution operations. You will lead deviations and CAPA, oversee change control, support validation/qualification activities, and serve as the primary quality liaison during client and regulatory audits.

Key Responsibilities

Quality Management & Compliance

• Implement, maintain, and continuously improve the QMS aligned with GDP, client Quality Agreements, and applicable HSA requirements.
• Own deviations/non‑conformances, root cause investigations (e.g., 5-Whys, fishbone), CAPA planning, effectiveness checks, and change control.
• Develop, author, review, and control QMS documentation (SOPs, WIs, forms) and ensure periodic review and version control.
• Define, collect, analyze, and report quality metrics/KPIs (e.g., temperature excursion trends, deviation and CAPA cycle time, audit findings).

Cold Chain & GDP Operations Support

• Review and approve GDP records: goods receipt, storage, pick/pack, outbound distribution, temperature monitoring, and exception handling.
• Lead temperature excursion management: initial containment, impact assessment with clients, stability/data review as applicable, and final disposition decisions per procedures.
• Oversee qualification/validation activities: temperature mapping of cold rooms/freezers, equipment qualification, calibration programs, packaging/shipper qualification, lane/route risk assessments, and WMS/temperature system changes.
• Ensure segregation and status control (quarantine/released/rejected) and proper labeling to prevent mix‑ups and cross-contamination.

Audits, Inspections & Supplier Quality

• Plan and conduct internal audits and external audits (e.g., transport partners, packaging suppliers, calibration vendors); track findings and drive timely CAPA closure.
• Serve as the primary liaison during client audits and regulatory inspections; coordinate readiness, host tours, and deliver timely, complete audit responses and documentation.
• Participate in quality risk management activities for routes, seasonal risks, shipper selection, and operational changes.

Training & Quality Culture

• Develop and deliver GDP training (onboarding, annual refreshers, targeted retraining) and maintain robust training records.
• Champion a continuous improvement and right‑first‑time culture across warehouse and transport operations.

Stakeholder & Documentation Management

• Collaborate closely with Operations, Warehouse, Transport, Commercial/Client Services, and IT to embed quality in daily activities.
• Review and maintain Quality Agreements with clients and service providers; ensure alignment with procedures and regulations.
• Support quality inputs for business continuity, deviation prevention, and change impact assessments (e.g., facility layout changes, equipment upgrades, WMS enhancements).

Pharmacist (Singapore) Requirements

• Must be a Registered Pharmacist with the Singapore Pharmacy Council (SPC) and hold a valid Practising Certificate.
• Provide professional oversight of handling of therapeutic products and health products in accordance with HSA and applicable GDP requirements.
• Where required by client agreements or regulations, endorse product disposition/release for distribution, and oversee handling of controlled items (if applicable), ensuring compliance with all legal and client-specific requirements.

Qualifications & Experience

• 3–6 years of relevant experience in pharmaceutical QA/QMS within GDP environments; 3PL cold chain experience is highly preferred.
• Strong knowledge of GDP, QMS, CAPA, change control, deviations, and audit management; familiarity with HSA requirements and PIC/S GDP standards.
• Experience with temperature-controlled logistics, including data loggers, monitoring systems, and validation/qualification (e.g., temperature mapping, shipper qualification).
• Proficient in root cause analysis, stakeholder management, and clear technical communication (written and verbal).
• Experience with QMS/eQMS tools (e.g., Veeva, TrackWise) and WMS/TMS is an advantage.
• Legally eligible to work in Singapore.

What We Offer

• Opportunity to impact patient safety in a growing 3PL.
• Collaborative culture with ongoing professional development and GDP upskilling.
• Competitive package and benefits.

Application

Interested candidates are invited to APPLY NOW or email an updated resume/CV to [e-mail] with the subject line:
“QA Specialist (Pharmacist)”

Please note: Only shortlisted candidates will be notified.