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QA MANAGER

 

Company:

BERKLEY-PHARMACEUTICAL
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Job Reference Number

13498415

Client ID:

RI/BPJH907.3
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Posted On:

Jun 19 2009

Location:

DUBLIN CITY CENTRE
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Job Type:

Permanent

Salary:

NEGOTIABLE
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Benefits:
  • CAR PARKING
  • PENSION / PRSA
  • BONUS
  • PAID HOLIDAYS
Our client, a pharmaceutical client, is currently recruiting a Quality Manager to join its Dublin based team in a permanent role

This is an excellent opportunity to join an innovative R&D facility with extensive growth planned for the next few years.

Role/Opportunity

  • Ensure compliance of all staff in the Company to cGMP and thus maintain IMB Licence for Clinical Trials Manufacture.
  • Manage and have full knowledge of the Quality System for the company facility i.e actively manage and partake as the driver of the change control, deviations, documentation system, internal audit system, APR, site master file and any other systems that affect the IMB licencing of the facility for cGMP.
  • Be responsible for the management of all company Audits these include but are not limited to:
  • Regulatory, Client, GXP and Supplier Audits.
  • Be responsible for championing Quality decisions throughout the organisation.
  • Review and follow up on documents as required as a support to Analytical and Formulations departments and QP for batch review and release.
  • Represent the Quality Department for all projects within the company
  • Responsible for ensuring all personnel are trained on cGMP and that refresher training is also carried out periodically.
  • Maintain knowledge of regulatory requirements current and revise QA systems accordingly.
  • Manage QA support of clinical manufacture.


Skills/Experience

  • Minimum of five years experience in a quality role in a pharmaceutical manufacturing facility, two of which must be at a supervisory/ management level. Internal auditing experience essential
  • Minimum third level qualification in an appropriate scientific discipline.
  • Experience of solid oral dose manufacture and early stage development a key advantage
  • Experience in auditing suppliers including API and excipient manufacturers, contract laboratories and other contract suppliers desirable.
  • Experience in Risk Management a key advantage
  • A working knowledge of GLP/GCP as applied to pharmaceutical development is desirable


Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia

For more information go to www.berkley.ie

To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Joanna Houston on +353 (0) 1 872 4665 or send your CV to pharma@berkley.ie