Health Products Regulation Group
Division: Audit & Licensing Division
Branch: Audit Branch
Position: Snr / Regulatory Specialist / Consultant
Responsibilities:
You will be responsible for the management and conduct of regulatory audits of local and overseas manufacturers as well as local importers/ distributors of medicinal products in accordance with the PIC/S Good Manufacturing Practice (GMP) standard, HSA Good Distribution Practice (GDP) Guidelines and the Singapore Medicines Act.
A Senior Regulatory Specialist/ Regulatory Consultant will also be responsible for strategic planning, formulating industry guidance and audit policies, planning audit and licensing programs and working in collaboration with relevant stakeholders to promote PIC/S GMP, HSA GDP Guidelines and other quality system standards. He/ She will also play active roles in international meetings and other regional ASEAN/ GMP and GDP harmonization initiatives.
Requirements:
- Minimum degree holder of a recognised scientific/ technological discipline related to pharmaceuticals (e.g. pharmacy, pharmacology, toxicology, chemistry, chemical engineering, biochemistry, microbiology)
- Preferably with 2-8 years experience in manufacturing and/or quality assurance/ control in the pharmaceutical/ biopharmaceutical industry.
- Knowledge in PIC/S, EU, FDA and international GMP standards.
- A team player who is able to work effectively within a group.
- Analytical and meticulous in nature.
- Good writing, communication and interpersonal skills.
- Good project management skills.
Interested applicants please email us your detailed resume to hsa_hr@hsa.gov.sg and indicate Snr/ Regulatory Specialist/ Consultant, Audit & Licensing Division on the subject header.
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