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QUALIFIED PERSON (QP)

 

Company:

HARMONICS RECRUITMENT & SEARCH
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Job Reference Number

14565815

Client ID:

RI/67543
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Posted On:

Feb 6 2012

Location:

GALWAY, CLARE
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Job Type:

Permanent

Salary:

65,000 - 75,000
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Benefits:
  • PENSION / PRSA
  • PERM. HEALTH INSURANCE
  • LIFE ASSURANCE
  • PAID HOLIDAYS
Our Multinational Pharmaceutical Client has a requirement for a Qualified Person. Duties:

  • Responsibility for batch release as per EU guidelines by ensuring the following requirements have been met:
    • the batch and its manufacture comply with the provisions of the marketing authorisation
    • manufacture has been carried out in accordance with GMP
    • the principal manufacturing and testing processes have been validated
    • any deviations or planned changes have been duly authorised.
    • all the necessary checks and tests have been performed;
    • all necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;
    • all audits have been carried out as required by the QA system;
  • Manage the internal audit schedule and conduct internal audits where appropriate.
  • Management of the site change control system and acting as Quality representative on the site Change review board when appropriate.
  • Management of the customer complaint handling system.
  • Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate and as per the external audit schedule.
  • Management of the site incident report/CAPA system. Performing detailed investigations or quality review of these reports as appropriate and required.
  • Quality review and approval of validation protocols and reports.
  • Update of the site quality system with recommendations for improvement where appropriate.
  • Performing quality review and approval of contract manufacturing documents for products as appropriate.
  • Management of the planned deviation system and performing quality review and approval as appropriate.
  • Performing product quality reviews as per the appropriate procedure and to the current schedule.
  • Take a lead role in regulatory/customer audits of the site as appropriate and when required.
  • Approval of Technical Agreements as appropriate and when required.
  • Preparation of and performing annual GMP training program.
  • Signing GMP declaration forms for API suppliers as appropriate and when required.
Education/Experience

  • QP Qualification essential
  • Degree in Science or related area
  • 6+ years experience in a QA, Quality or regulatory role within a Pharmaceutical multinational