About the role

AI summarised

This role is for a Quality Compliance Specialist at Takeda's biologics manufacturing facility in Singapore, responsible for site quality compliance governance, inspection and audit management, and product quality communications. The specialist ensures regulatory compliance, leads self-inspections, manages quality councils, and handles customer complaints and product recalls.

BiopharmaFull-timeQuality

Key Responsibilities

Support to host and manage regulatory inspection and communications.
Support and ensure the site is inspection ready at all times.
Lead and support the site inspection readiness activities.
Lead Auditor to lead the self inspection program and plan for self inspection schedule.
To perform supplier qualification which include supplier audit.
Participate and lead 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 requirement for Quality Council and Quality Risk Register.
Participate in any corporate/division alignment meetings for information learning & sharing and alignment of best practices.
Responsible for reporting site KPIs and matrix to the site management.
Host and manage monthly Quality Councils meeting.
Oversight and manage site Quality Risk Management.
Participate and lead 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 requirement for Product Recall Quality.
Ensure timely investigation and report for customer complaints and product recall.

Requirements

University degree in Biotechnology, Chemistry, Pharmacy, Science, Engineering or equivalent.
At least 5-7 years of experience in Pharmaceutical or related manufacturing environment.
Demonstrated ability to collaborate with cross functions or cross sites to achieve objective.
An ability to interact and communicate with all types of personalities in an effective and diplomatic manner.
Ability to create and mediate common understanding and communicate expectations on compliance.
Presentation skills for audit, training and Senior Management.
Substantial knowledge in regulatory requirements, such as Eudralex, 21CFT, ICH, etc.
Able to logically solve problems in order to find timely solutions.