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Project Quality Assurance Manager, Asia

Keywords / Skills : Project Quality Assurance Manager, Asia

7 - 10 years
Posted: 2019-01-03

Industry
Recruitment/Staffing/RPO
Function
IT
Role
Regulatory Affairs Executive
Posted On
3rd Jan 2019
Job Ref code
27339
Job Description
Job Description :

Our client is a global pharmaceutical company with clinical nutrition and generic drugs. currently looking for

REPORTING TO
Global Operation QA Head

POSITION OVERVIEW:
The Project QA Manager is responsible to support the Plant Quality Managers in the GO in the implementation, maintenance and adherence to the Plant Quality Management System and to ensure that it is compliant with the Corporate procedures and all relevant Regulatory and Certification requirements
She/he assures that all products are manufactured and released in compliance with the Quality Management System, registration dossiers and GMP requirements.

SPECIFICS:
  • Assure execution, maintenance and improvement of the Quality Management System at all plants within the Asia GO together with the Plant QA Manager.
  • Assure compliance with the Quality Management System at all plants in Asia together with the Plant QA Manager.
  • Assure GMP/regulatory compliance at all plants in Asia together with the Plant Manager and Plant QA Manager.
    • Assure together with Local Quality Management by means of regular Quality audits that the Plant Quality Systems comply with Corporate procedures and all relevant regulatory and certification requirements.
  • Oversight of LIMS project implementation in GO Asia
    • Provision of management support and guidance to LIMS SME
  • Where possible, harmonise the common Operating Procedures related to the quality system at all the plants in Asia GO.
  • Assure that the Global and Divisional SOPs, WIs and GDs are implemented in the Region.
  • Where possible, harmonise and centralise the procedure and qualification activities for vendors shared by plants in Asia. Support the vendor audit programme.
  • Support the plants in the inspection readiness programme prior to regulatory inspections. In addition, provide support in the preparation and review of responses.
  • Support the plants during and after internal audits
  • Enhance quality educational level at all plants within the Asia region.
  • Liaise with Quality organizations of other GOs, I&D Centres and Divisions with the purpose of benchmarking against each other and share lessons learned.
  • Ensure that the procedures/Manufacturing processes filed with regulatory agencies are followed on a routine basis
  • Assist in the audits of third party manufacturing sites and implementation of technical agreements
  • Propose and support quality related investment projects
  • Support the Plant QA Manager in quality investigation projects arising at the plants.
  • Escalate Quality issues to the GO QA Head
  • Quality metrics data review on a monthly basis
    • Review of the monthly Quality Key Performance Indicators reported by plant.
    • Regular review of the data to ensure the events/actions are closed in a timely manner.
    • Review of the effectiveness check data generated against CAPAs.


OTHERS
  • An independent working personality with high skills and experience (+ 7 years) in pharmaceutical manufacturing and experience in an international operating pharmaceutical company is preferred. University degree in pharmaceutical/biological or chemical science is a requirement and experience in aseptic manufacturing and understanding of microbiological topics is a prerequisite.
  • Open and positive character with excellent communication skills that is able to motivate people.
  • Due to the regional nature of the position the role will involve travel nationally and internationally
  • Compliance with the Code of Conduct
  • Proven leadership, high integrity and communication skills
  • Fluent in English

Qualified and interested Parties please apply with your CV and latest salary in Word format to.



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