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QUALIFIED PERSON (QP)

 

Job Reference Number

13649870

Client ID:

RI/441477B

Posted On:

Jul 20 2009

Location:

DUBLIN SOUTH

Job Type:

Permanent

Salary:

65000 - 75000

Benefits:

  • SPORTS & SOCIAL CLUB
Job Title: QP

Reporting to: QA Manager, QP

Your duties will include, but will not necessarily be confined to:



Responsibility for the day-to-day management of the QA and QC function within the company.

  • Management of QA Executive, QA Documentation Controller and QA Inspectors. QC Supervisor and QC Analysts.


  • Acting as Qualified Person on behalf of the company -responsible for the review of batch manufacturing records and manufacturing release follow up on product complaints/ recall where necessary. Making release and manufacturing decisions in compliance with all manufacturing and MA license requirements


  • Ensuring that the documentation control system is up to date.


  • Ensuring that all batch card QA review is scheduled completed on time and logged.


  • Carry out problem investigation; recommend corrective actions and track agreed follow up actions.


  • Responsibility for the management of the Deviation Control System, ensuring deviations are recorded, discussed via regular scheduled meetings and corrective actions agreed and implemented in a timely manner.


  • Management of change control system.


  • Review and approval of SOP's.


  • Administration of and QA close out of customer complaints.


  • Management of internal audit programme, ensuring that any corrective actions/deviations/process (procedure) changes are properly documented and executed.


  • Management of vendor audit programme.


  • Management of GMP training programme.


  • Carry out any other tasks assigned by the QA Manager.



  • PERSON SPECIFICATION

    Educational Standards



    A degree in Chemistry, or a related discipline Postgraduate qualification allowing the applicant to act as a Qualified Person within the EU

    Personal Attributes, Skills and Experience

  • At lease 1 years experience as a QP releasing product with in the EU
  • Previous experience as a managing a Quality Function , leading a team and delivering on objectives
  • A keen eye for detail is essential with knowledge of cGMP compliance.
  • An analytical mind with good problem solving capabilities
  • Self motivation and initiative as this position will involve both working as an individual and as part of a team.
  • If you would like to discuss this position please contact Stephen Curtin at scurtin@brunel.ie
    or phone 01 432 1510