Senior/Regulatory Specialist, Audit Branch

• Lead the conduct or conduct of local and overseas regulatory inspections or conformity assessment of manufacturers and dealers of health products and pharmacies ensuring that they conform to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), regulatory requirements and other relevant quality system standards.
• Lead/assist in the review of regulatory policies and legislations related to manufacturers and dealers of health products and active ingredients and the translation into specific technical and operational plans for implementation to achieve the desired outcome.
• Lead/assist in the review, development and implementation of technical standards, industry guidelines, internal good practice guidance on GMP inspections
• Lead/assist the effective implementation of the AB’s Quality Management System (QMS) in accordance with Phamaceutical Inspection Co-operation Scheme (PIC/S), ISO 9001 standard and other international standards, e.g., WHO ML4 & WLA.
• Work in collaboration with international colleagues to facilitate technical liaison with other regulatory authorities and relevant bodies in the field of GMP inspection (e.g., inspection reliance, mutual recognition agreement, standard harmonisation).
• Lead/assist in the management and handling of stakeholders’ technical and procedural enquiries.
• Lead in/assist with performing assessment of changes (URS, UAT, etc.) to electronic processing systems for inspection and licensing.
• Lead/assist in the inspection scheduling and monitoring of performance indicators related to inspections.
• Assist the Branch Director and Unit Deputy Director in ensuring that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the inspection teams.
• Perform such other duties as the department may reasonably require.

• Possess relevant knowledge in scientific or technical disciplines related to health products, such as pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biochemistry, biotechnology, microbiology, or related fields.
• Relevant experience in pharmaceutical or biopharmaceutical manufacturing and/or quality functions is required. The role is suited to candidates with several years of experience (typically 2–5 years or more). Exposure to sterile manufacturing or aseptic processing would be an advantage.
• Good understanding in the current international regulatory landscape and developments in the field of manufacture of biopharmaceutical or cell, tissue and gene therapy products.
• Passion for GMP inspection work with good knowledge and experience in international GMP standards (e.g., PIC/S GMP).
• Willingness to travel for overseas inspections and related assignments, where required for operational needs
• Ability to work as part of a multidisciplinary team.
• Familiar with the use of computer softwares including word and data processing applications.
• Communicates both orally and in writing effectively.
• Proficiency in English is required. Knowledge of additional languages is an advantage.
• Candidates without prior working experience are welcome to apply

The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance.

Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.