QUALIFIED PERSONWATERFORD

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CAREERWISE RECRUITMENT

  • CORK,
  • SHANNON, GALWAY
  • MAYO, DUBLIN
  • Job reference number:15410942
  • Client ID:RI/CW121802
  • Posted on:30-NOV-2018
  • Salary:NEGOTIABLE
  • Location:WATERFORD, WATERFORD
  • Job type:PERMANENT

A Qualified Person is required by CareerWise Recruitment for our South East based based pharma client.

The QP ensures that all products being released for clinical trial purposes comply with the requirements of the Clinical Trial Authorisation and have been manufactured according to the principles of GMP as per Directive 2003/94/EC.

THE ROLE:
* To ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the cGMP/cGLP/Regulatory requirements.
* To develop and improve quality systems by identifying areas for improvement and take corrective action as required
* To review change proposals and related documentation for compliance with Regulatory approvals and GMP requirements.
* To ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLPs, SOPs, regulatory regulations an
* To review and approve batch documentation, investigation reports, change requests, SOP's and qualification reports, ensuring they are completed right first time and in full in accordance with Good Manufacturing Practice requirements.
* To review and release batches according to shipment schedule ensuring all batches are in compliance with regulatory requirements

REQUIREMENTS:
* Proven previous experience within the Pharmaceutical industry in a QA/QC/Compliance role.
* Qualified Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or equivalent "Qualified Person" status as defined by E.C. Directive 2001/83.
* Experience of Product development and Clinical Programs will be an advantage.
* Experience of Combination Products, Medical Devices will be an advantage.
* Excellent knowledge of regulations and sources of regulatory information.
* Excellent knowledge of company procedures, policy and standards.
* Understanding of Production and Laboratory systems to effect judgement decisions consistent with business needs.
* Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence.
* An understanding of internal/external customer requirements and an ability to respond promptly to needs

Please call Brian Flynn today for further information on 021 4297423 or email: bflynn@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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This job originally appeared on RecruitIreland.com