Senior/ Regulatory Specialist, Audit Branch

[What the role is]

[What you will be working on]

• Lead the conduct or conduct of local/overseas regulatory inspections and licensing 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.
• Lead in/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.
• Work in collaboration with international colleagues to facilitate technical liaison with other regulatory authorities and relevant bodies in the field of GMP inspection.
• Perform such other duties as the department may reasonably require.

[What we are looking for]

• Possess relevant knowledge in scientific or technical disciplines related to health products, such as pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biochemistry, biotechnology, microbiology, genetic/tissue engineering. Or related fields.
• Relevant experience in pharmaceutical or biopharmaceutical manufacturing and/o rquality 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 biopharmaceuticals 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 inspection work and related work 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 experience but with the releavnt scientific/technical qualifications 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.