Quality Specialist (Quality Management System/ ASEAN)

Location Singapore
Discipline Pharmaceutical
Job Reference BBBH116507_1658293066
Salary S$7000 - S$10000 per month
Consultant Email apple.lim@manpower.com.sg
EA License No. 02C3423


Quality Specialist (Quality Management System/ ASEAN)

12-Month Contract
Industry : Pharmaceutical
Salary up to $10,000 depending on experience

Job overview

  • Manage third party manufacturers located in China and ensure that manufacturing operations are conducted, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.
  • Support on the QMS and all projects related to New product launches in performing Due Diligence.



Responsibilities
Quality Management of third party manufacturers

  • Perform GMP audits of third party manufacturers and CAPA (Corrective action and preventive action) follow-up.
  • Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
  • Management and support product recall and return.
  • Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
  • Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
  • Participate in the evaluation, selection and approval of third party manufacturers
  • Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
  • Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
  • Review of technical reports e.g. stability reports, process /analytical validation reports etc.
  • Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
  • Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
  • Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third party manufacturers.
  • Perform risk ranking of third party manufacturers.
  • Manage termination of activity with third party manufacturers.



Quality Operations of EM CHC China Entity

  • Support/perform management and continuous improvement of Quality Management System (QMS).
  • Support/perform implementation of global quality standards and procedures.
  • Support Quality Documentation System management, documentation Retention, Archival and Destruction.
  • Support/perform Qualifications and Training of Quality/Regulatory personnel.
  • Support/perform Self Inspection.



Quality Support for Transversal Projects

  • Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation.



Requirements & Qualifications

  • Degree in Pharmacy / Pharmaceutical Science / Related Science
  • At least 5 years working experience in quality or manufacturing in pharmaceutical industry.
  • In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations).
  • Computer skills: Word, Excel, Phenix (Quality tool), GEODE+ (GMP Documentation system).



If you possess above relevant skillsets, please send in your updated CV in word format to Apple.lim@manpower.com.sg

Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup's Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy