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Qualified Person

Job description

QUALITY SPECIALIST/ QP

JOB RESPONSIBILITIES:

  • For the Manufacturing license, act as one of the Company’s Qualified Persons in accordance with EU Directive 2001/83/EC.
  • To act as the QP for  the production plant.
  • Role of QP to include
    • Direct contact with relevant production Coordinator on GMP issues.
    • Cooperation with Production to ensure continuous improvement
    • Provide details on corrective actions required for batch deviations
    • Assist in the implementation of Quality Systems within production to ensure compliance with GMP
    • Provide regular feedback to other QP’s on main issues
  • To act as QA representative on major projects as required.
  • Communication / liaison with other departments.
  • Participate in the vendor audit program.
  • Participate in the self-inspection programme.
  • To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
  • Maintenance of the Quality Systems

JOB REQUIREMENTS: 

  • Have a minimum of five years experience in the Pharmaceutical Industry in a QA role.
  • Packaging experience a distinct advantage
  • Will look at candidates who are eligible for QP but not practicing and candidates who are studying to be a QP and not yet finished

Please review the requirements for this job and apply to Clara Henry on chenry@sigmar.ie or phone 01 4744676 for more detail.

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