Qualified Person- Pharmaceuticals

South West England  ‐ Onsite
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Description

One of the largest Brands within Pharmaceuticals is currently looking to hire an Qualified Person to undertake batch release for the fast paced manufacturing site. Reporting directly to the head of Quality, you will carry out the duties of a Qualified Person as defined in the EU guide to GMP and to provide resource for the certification of batches for release to market in accordance with the relevant EU directives.

Specific Requirements:
  • Responsible for supporting deviation close out, writing investigation reports and initiating/following up on corrective and preventative actions
  • Leading Quality based projects working as part of a multidisciplinary team as required
  • Responsible for supporting quality related customer complaint investigations and trending activities
  • Supporting the development and implementation of improved quality reporting measures
  • To promote continuous improvement of the Pharmaceutical Quality System
  • Able to provide direct support during customer and regulatory audits
  • Approving pre and post execution validation documents
  • Able to conduct self inspections and external audits as appropriate
  • Able to provide training in all aspects of Pharmaceutical Quality System and GMP including procedural updates
  • The generation of Product Quality Reviews, Technical Agreements and Summary of Finished Product Specifications as appropriate
  • Responsible for supporting the review of all batch related documentation prior to product release
  • Conducting routine QP duties in accordance with the EU guide to GMP and Certifying finished product batches for release to market


Relevant Skills:
  • Higher National Certificate or Degree in science discipline
  • Proven experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry
  • Knowledge of EU quality related pharmaceutical regulations
  • Experience of conducting quality based investigations and root cause analysis
  • Experience of conducting self inspections
  • Understanding of solid dose manufacture
  • Understanding of Product Quality Review requirements
  • Good communicator
  • Decisive thinker able to work within agreed timescales
  • Member of either Royal Pharmaceutical Society, Institute of Biology or Royal Society of Chemistry
  • Eligible QP under the permanent provisions of EU Directive /EC.


The organisation is on the cusp of huge expansion with opportunity for future development, internationally as well as in the UK. They are also willing to offer a relocation package if necessary.

If you are interested in this position please email an updated CV to Sophia Harding or call for further details.
Start date
03/2015
From
Real Staffing
Published at
06.05.2015
Project ID:
898947
Contract type
Permanent
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