About the role
AI summarisedThis role is responsible for site quality compliance governance and product quality and compliance communications at Takeda's biologics manufacturing facility in Singapore, supporting the achievement of site objectives.
BiopharmaOnsiteQuality
Key Responsibilities
- Support and manage regulatory inspections and communications, ensuring the site is always inspection-ready.
- Lead self-inspection programs and plan inspection schedules as Lead Auditor.
- Lead and participate in the rollout of Quality Systems, ensuring implementation aligns with regulatory and corporate requirements.
- Report site KPIs and matrices to site management.
- Host and manage monthly Quality Councils meetings.
- Oversee and manage site Quality Risk Management activities.
- Ensure timely investigation and reporting for customer complaints and product recalls.
- Coordinate and report product quality issues to health authorities through the quality incident management process.
Requirements
- University degree in Biotechnology, Chemistry, Pharmacy, Science, Engineering, or equivalent.
- At least 5-7 years of experience in a Pharmaceutical or related manufacturing environment.
- Demonstrated ability to collaborate effectively with cross-functional and cross-site teams.
- Substantial knowledge of regulatory requirements such as Eudralex, 21CFT, and ICH.
- Proven ability to interact with diverse personalities diplomatically and communicate expectations regarding compliance.
- Strong presentation skills for audits, training sessions, and Senior Management.