Qualified Person QP

Location
Wicklow
Salary
Negotiable
Posted
10 April 2018
Closes
08 May 2018
Ref
QP2CH
Position / level
Professional
Contract Type
Permanent
Hours
Full Time

Job Description

Qualified Person QP

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

Requirements: 

  • Possesses suitable educational background that meets the requirements of Article 49 of Directive 2001/83/EC.
  • Have a minimum of five years experience in the Pharmaceutical Industry in a QA role.
  • Direct QP experience in solid oral dosage manufacture and/or packaging is preferable - but must be QP eligible.

Please review the requirements for this role and apply to Clara Henry - click APPLY or phone 01 4744676 for more detail.

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