Posted to MedZilla on 9/22/2019


Takeda Pharmaceuticals

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

Operations

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

Leadership

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

EHS

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.


Please visit our website at takedajobs.com

 
 


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