Job Responsibilities
- Maintain and continuously improve the Quality Management System (QMS) in compliance with cGMP, PIC/S, USFDA, ASEAN, ICH, GLP and other regulatory requirements.
- Oversee qualification and validation activities (e.g. IOPQ, MV, CV, PV), manage change controls, deviations, CAPA, and ensure proper documentation control (SOPs, quality records, specifications).
- Review production and quality documents, generate CoA, and support batch release in the absence of the QA Manager.
- Handle quality issues, customer complaints, product recalls, supplier qualification, packaging artwork control, and stability study programmes.
- Prepare Product Quality Review and management review reports, and support ongoing compliance and audit readiness.
Job Requirements
- Min Diploma in Pharmacy, Life Sciences, Applied Chemistry or equivalent.
- At least 2 years of Quality Assurance/Quality Control experience in pharmaceutical manufacturing.
- Strong knowledge of PIC/S GMP, USFDA cGMP, EMA, ICH frameworks hands-on experience in qualification, validation, CAPA, change control, risk management familiarity with ISO 9001 is an advantage.
- Meticulous, well-organised and detail-oriented with strong communication, problem-solving, stakeholder management skills proficient in Microsoft Office (Excel, Word).
Interested candidates who wish to apply for the advertised position, please click APPLY to submit your application or send in your resume to [Confidential Information]
EA License No: 13C6305
Reg. No.: R1874608 (Lee Jia Hou)
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