Qualified Person

Wicklow  ‐ Onsite
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Description

Pharmaceutical company based in Co. Wiclow is seeking a QP to join their Qualiy Team.

For the Manufacturing license, act as a Qualified Person in accordance with EU Directive /EC. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.
Key Areas of Responsibility:
  • Cooperate 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 for relevant production plant
  • To act as Quality representative on major projects as required.
  • Communication / liaison with other departments.
  • Participate fully in any cross-functional training initiatives.
  • 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 within The company.
  • Other duties as required and as directed by the Senior Director, Quality or other officer appointed by the Board of Directors.


The successful candidate will have:
  • Have a minimum of five years experience in the Pharmaceutical Industry in a QA role.
  • QP experience in solid oral dosage manufacture and/or packaging is preferable
  • Good organizational, investigational & technical writing skills are required
  • Be a self starter who is motivated & innovative
  • Possesses suitable educational background that meets the requirements of Article 49 of Directive /EC.


If you are interested in hearing more information on the role and the company please apply below with an up to date CV.
Start date
07/2015
From
Real Staffing
Published at
12.06.2015
Project ID:
923296
Contract type
Permanent
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