Quality Excellence Supervisor
Full-Time
Singapore, Singapore
Health & Biotech
Health & Biotech
Description
- Operations
- Lead a team of Quality Excellence Specialists to support site investigations relating to Manufacturing/ Engineering/ Validation/ Logistics/ Supply Chain Planning/ Laboratories/ Incoming Material Release and review/approve the investigation report.
- Lead the team to ensure timely review and approval of investigations to support release of BDS and raw material.
- Lead the team to ensure timely review and approval of change controls to support implementation of changes with exceptions to raw material, computer system validations and new equipment.
- Lead the team to ensure timely review and approval of investigation in the event of customer complaints and product recall.
- Facilitate and lead quality process such as daily deviation tracking to provide guidance and drive deviation investigation progress and closures.
- Support and lead the reporting of deviation-related metrics.
- Lead and participate in improvement initiatives within Quality Team.
- Participate and lead in any corporate/division alignment meetings for information learning & sharing and alignment of best practices.
- Participate and lead in quality system(s) rollout by ensuring that the elements of the assigned quality system(s) is/ are implemented and maintained at the site according to regulatory, corporate and division requirements for deviation and change control management systems.
- Support the compliance, audit, regulatory and training activities as required, and any other responsibilities as assigned by Supervisor
- Leadership
- Manage, coach and develop Quality Excellence specialists and contribute to the growth of those professionals.
- Ensure succession planning by identifying and grooming high potential employee to be the successor for the supervisor role to ensure business continuity.
- Build strong partnership with all other departments to ensure open communications and acceptance.
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.
Qualifications
- The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or related discipline.
- A minimum experience of 7 years (with at least 3 years in senior position) in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.
- Understanding of FDA/EU and ICH guidelines and any exposure/experience to the international regulatory network/audits will be of advantage.
- Six sigma greenbelt certification would be of advantage.
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