This position supports the Audits Branch in implementing regulatory inspection and licensing regimes to ensure health products meet quality, safety, and efficacy standards to safeguard public health
Job Summary
This position supports the Audits Branch in implementing regulatory inspection and licensing regimes to ensure health products meet quality, safety, and efficacy standards to safeguard public health.
The role involves leading local and overseas inspections, reviewing regulatory policies, and collaborating internationally to facilitate technical liaison with other regulatory authorities.
The successful candidate will be offered a 1-year contract with an option for automatic renewal for a further year.
Matching Summary
This position supports the Audits Branch in implementing regulatory inspection and licensing regimes to ensure health products meet quality, safety, and efficacy standards to safeguard public health.
Skills & Requirements
Must-have
Regulatory inspections and audits
Good Manufacturing Practice (GMP)
Quality Management System (QMS) implementation
Pharmaceutical or biopharmaceutical manufacturing experience
International regulatory standards knowledge
Stakeholder management and liaison
Proficiency in English communication
Nice-to-have
Exposure to sterile manufacturing
Experience with aseptic processing
Knowledge of additional languages
Ability to work in multidisciplinary teams
Use of word and data processing software
Willingness to travel overseas
Key Requirements
2–5 years pharmaceutical or biopharmaceutical experience
Relevant scientific or technical discipline knowledge