- Position title: QA Executive (3mths contract - convertible to full time)
- Location: Nearest mrt Redhill
- Working days: 5 days [ Mon - Fri ]
- Working hours: 8:30am - 530pm
- Salary : $3,000 - $4,000
Job Duties and Responsibilities:
- Maintain & continuously improve the Quality Management System (QMS)
- Ensure compliance with cGMP, PIC/S, USFDA, ASEAN guidelines, ICH, GLP, Marketing Authorization & other regulatory requirements.
- Ensure Qualifications & Validation program (e.g. IOPQ, MV, CV, PV) meet compliance requirements.
- Serve as the document controller for the Quality Manual, SOPs, Specifications, Forms, records and quality reports.
- Generate CoA, review production & quality documents to authorize finished product batch to be Release for Sale in absence of QA Manager
- Prepare annual Product Quality Review & management review reports.
- Manage & follow up on change controls.
- Conduct deviation investigations & follow up on CAPA implementation for proper closure.
- Handle quality issues in manufacturing operations.
- Manage customer complaints & product recalls (if any).
- Review & control artwork & drawings for packaging materials.
- Manage the qualification of new suppliers and periodic re-assessment of approved suppliers of Starting Materials & Packaging Materials.
- Monitor accelerated & real-time stability study program.
- Undertake additional tasks as assigned from time to time.
Requirements:
- Possess diploma or degree in pharmacy, life science/applied chemistry or equivalent from established university.
- At least 3 years of proven Quality Assurance or Quality Control experience in a pharmaceutical manufacturing environment.
- Strong knowledge of PIC/S GMP and/or USFDA cGMP / EMA / ICH framework with hands-on experience in Qualification & Validation are preferred.
- Additional knowledge or experience in ISO 9001 is an advantage.
- Familiar with risk management tools/principles.
- Documentation & Processes: Experience in CAPA (Corrective and Preventive Actions), change control, document control, and validation processes.
- Proficient in Microsoft Office (Excel, Word)
Interested applicants can also send your resume to WA:+65 83472904 (Mr Samuel) and allow our Consultant to match you with our Clients.
No Charges will be incurred by Candidates for any service rendered.
Samuel Siaw
The Supreme HR Advisory Pte Ltd
EA No: 14C7279
Reg No: R2412474
