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Quality Specialist - Supplier Quality - Pharmaceutical

  1. Dublin
  1. Contract
Competitive
J025773WP
  1. Compliance / Quality Assurance
Date Posted10 Nov 2020
Quality Specialist - Supplier Quality/CMO - Drug Product - 12 months

Quality Specialist required for Global External Drug product manufacturing facility. 

Working within a state of the art Multi-Product Cell Culture Biologics Manufacturing facility, you will be responsibe for quality and compliance oversight within external manufacturing. 

Covering : Complaints, change controls, deviations and supporting quality operations on the CMO site.

Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
  • Deal with Quality complaints, change controls, deviations and supporting quality operations on the CMO site.
  • Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
  • Coordinate quality metrics programs in relation to Third Party performance.
  • Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
  • Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
  • Review the Annual Product Reviews submitted by the Third Party Manufacturers.
  • Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
  • Provide support to specified quality and technical projects as they arise.
Skills & experience required:

  • In depth knowledge of cGMP regulations 
  • Strong communication and presentation skills across all levels both internal and external 
  • A BSc in a scientific discipline such as Chemistry or Microbiology
  • Minimum 4 years’ experience in the pharmaceutical industry, preferably in Quality,
  • Manufacturing Technology, Regulatory or a position within a Health Authority Agency
  • Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
  • Contract Manufacturing Organisation experience/Quality Systems
  • Direct experience in interfacing with external manufacturers

 Based in Dublin - optional home working, but you may be required to go into the office.
Call me for further information on this role!

The candidate must have the rights to work in the location stated in the job advert.

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