Pharmaceutical & Biotechnology

Qualified Person

  • Contract
  • Dún Laoghaire, County Dublin, Ireland
  • 41994520

PE Global is currently recruiting for a Qualified Person for a leading multi-national Pharma client based in Dublin.

This is a 12 month contract position.

Role:

  • Perform activities as required per company procedures as QA staff, and in particular where the role of QP is specified in the procedures
    • Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
    • Perform review and approval of validation documentation.
    • Lead and participate in internal and external audits as needed.
    • Maintain a close contact and familiarity with the clients Quality systems and programs utilized at other client sites.
    • Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
    • Evaluates and assess change control records, non conformances and CAPAs.
    • Participate in global Quality initiatives as a site subject matter expert.
    • Participate or lead projects and improvement efforts including product launches.
    • Supports the evaluation of quality and distribution complaints.
    • Supports regulatory inspections or various questions from regulatory bodies.

Requirements:

  • Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 5 years OR minimum of 2 years experience as a practising QP.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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