Job Description

This position serves to support the Audits Branch (AB) in implementing the regulatory inspection and licensing regime, policies and initiatives governing the full spectrum of dealers across various health product categories in Singapore so as to meet HSA\xe2\x80\x99s national objective of ensuring that these health products meet the required standards of quality, safety and efficacy to safeguard public health and safety.

• Practice (GDP), regulatory requirments and other quality system standards as appropriate.
• 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, good practices for inspections of pharmaceutical facilities.
• Lead/assist the effective implementation of the AB\xe2\x80\x99s Quality Management System (QMS) in accordance with Phamaceutical Inspection Co-operation Scheme (PIC/S), ISO 9001 standard and other internal standards, e.g., WHO ML4 & WLA.
• Lead in/assist in the management and handling of stakeholders\xe2\x80\x99 technical and procedural enquiries.
• Lead in/assist with performing assessment of changes (URS. UAT, etc.) to electronic processing systems, e.g., PRISM.
• 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.

Job Requirements

• 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 manufacture of non-sterile and/or sterile products.
• Passion for inspection work with good knowledge and experience in GMP inspection processes relating to international pharmaceutical standards will be advantage.
• 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.

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