Singapore-, Quality Excellence Supervisor SR0040301-MZ
This position is required to lead the Quality Investigation Engineering Excellence team which is Quality representative and partner for the site to ensure GMP compliance at Takeda Singapore.
Quality Systems Representative
Lead a team of Quality Excellence Specialists in ensuring Quality oversight for the site with respect to Deviation Management/Change Control.
Partner the departments (e.g. manufacturing, engineering operations, PDTS and QC) and helping with implementation and adherence to the Deviation/Change Control related Quality systems and GMP requirements
Participate in any corporate/division alignment meetings for information learning & sharing and alignment of best practices
Assume the responsibility of document owner for documents from the area of responsibility.
Together with the SME, assist and approve the gap analysis for current SOP/practices with the various subject matter expert to ensure compliance with DPs/DMs revision, and where gaps are identified, proposed mitigation plans for Deviation/Change Control Management System
Participating in investigations to support site wide deviations/change control and review/approve the investigation report.
Ensure timely review and approval of investigations to support timely release of BDS and raw material.
Support deviations/change control-related metrics for site and global reporting.
Lead and participate in Improvement initiatives Quality Team, and not limited to Deviation/Change Control Management System.
Review and approve test scripts, protocols associated with deviations/change control.
Ensure documents relating to deviations/change control are properly and timely archived.
Reviewing/approving Change Controls for supporting areas
Support the compliance, regulatory, audits and training activities as required and any other responsibilities as assigned by supervisor
Manage, coach and develop Quality Excellence specialists and contribute to the growth of those professionals.
Ensure succession planning by identifying and groom 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
Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct
Responsibility to adhere to any applicable EHS requirements
Any other duties as assigned by supervisor.
Education and Experience Requirements
The candidate should have at least a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline. Additional certification and trainings such as auditor training or QP training will be advantageous.
At least 7 years in pharmaceutical industry, with 3 years in a senior position, in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, ideally in a multinational company.
FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network.
Six Sigma Greenbelt certification would be advantageous
Key Skills and Competencies
Good knowledge in the various regulatory requirements
Process and product knowledge is preferred
Product Release knowledge is preferred
Able to logically solve problems in order to find timely solutions
An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
Good presentation skills to conduct training and support audits and
Serves as a delegate for QA manager in her absence and approve any QA related documents.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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