Skills

Full description

Directs all plant-level Quality Assurance (QA) and Quality Control (QC) operations. This strategic leadership role ensures that pharmaceutical products are manufactured, tested, and released in strict compliance with cGMP, FDA, EMA, and PIC/S regulatory standards
QMS Management: Establish, optimize, and maintain the Quality Management System (QMS) to ensure 100% regulatory compliance.
Compliance & Audits: Oversee customer audits, regulatory inspections, deviation investigations, and Corrective and Preventive Actions (CAPA).
Batch Release: Review and approve validation master plans, batch records, and product specifications to guarantees afety and product efficacy.
Team Leadership: Manage, train, and evaluate the performance of site QA/QC teams, fostering a robust quality culture across the facility.
Stakeholder Alignment: Represent the Quality function in cross-functional project teams and ensure customer quality agreements are met
Bachelor's Degree in Pharmacy, Chemistry, Life Sciences, or Chemical Engineering
10+ years of pharmaceutical quality assurance management, with at least 5 years in a supervisory or leadership role.
Deep, hands-on knowledge of GMP manufacturing, ICH guidelines, data integrity protocols, and health authority regulations

Veronica Neo Shen Hwa - veronica.neo@manpower.com.sg

Personnel Reg No: R1110855

Manpower Staffing Services (S) Pte Ltd

EA Licence No: 02C3423