Senior/Regulatory Specialist
3 weeks ago
i)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.
ii)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.
iii)Lead/assist in the review, development and implementation of technical standards, industry guidelines, internal good practice guidance on GMP inspections
iv)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.
v)Lead in/assist in the management and handling of stakeholders’ technical and procedural enquiries.
vi)Lead in/assist with performing assessment of changes (URS, UAT, etc.) to electronic processing systems for inspection and licensing.
vii)Lead/assist in the inspection scheduling and monitoring of performance indicators related to inspections.
viii)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.
ix)Work in collaboration with international colleagues to facilitate technical liaison with other regulatory authorities and relevant bodies in the field of GMP inspection.
x)Perform such other duties as the department may reasonably require.
Job Requirements
•Relevant recognised degree, preferably in scientific disciplines, e.g., pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biochemistry, biotechnology, microbiology, genetic or tissue engineering.
•Preferably with 2-5 or more years of experience in manufacturing and/or quality assurance/control in the pharmaceutical/biopharmaceutical industry, with good understanding in the sterile manufacture and aseptic processing of pharmaceutcal products.
•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).
•Familiar with the use of computer softwares including word and data processing applications.
•Communicates both orally and in writing effectively.
•Bilingual or multilingual including fluency in English.
•Ability to work as part of a multidisciplinary team.
•Ability to travel for overseas inspection work assignments.
•Fresh graduates may also be considered if they have the appropriate scientific qualification/experience with right personal attributes.
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