Qualified Person

  • Department: Quality
  • Location: Hampden Park, Eastbourne
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 27-Feb-2017

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Overview

Have you got a background in Quality backed up by experience gained in the industry?  Then you might be just what we're looking for at Teva....

We are looking to recruit a Qualified Person for our highly successful quality team, the successful QP will be based at our Eastbourne site. Reporting to the Head of Quality, you will ensure that products sold by the Company meet the required quality standards to ensure patient and company safety.

As the Qualified Person (QP), you will be able to fulfill the requirements in respect of a Qualified Person: Taking responsibility for and on behalf of the company as the holder of a manufacturing authorisation by certifying batches for release, intended for commercial sale. In doing so, the QP must ensure that a product is fit for its intended use, complies with the requirements of the relevant Manufacturing License, the Marketing Authorisation (MA) and does not place patients at risk due to inadequate safety, quality and efficacy. 

Teva are an essential part of the UK Healthcare sector, we’re a company that makes a difference to millions of people’s lives, day in and day out. We make hundreds of different medicines, treating patients for conditions ranging from hay fever to cancer. Our key therapy areas include central nervous system conditions, respiratory, pain, oncology, mental health and urology.


Skills & Experience

To be considered for the role of Qualified Person you should be educated to degree level (as a minimum) and should hold previous experience as a Qualified Person with a current manufacturing license. Ideally you should hold previous experience of managing/releasing 7/8 batches per day.

Main Responsibilities

  • Act as a Qualified Person in accordance with the duties as defined in Article 51 of the Directive 2001/83 EC, Annex 16 of EU GMP guidelines and the code of Practice for Qualified Persons.
  • To ensure that the principles and guidelines of GMP have been met during manufacturing, packaging and testing operations for all products for which Teva UK Eastbourne is the named site of batch release.
  • To verify that all batch related documentation is compliant with the requirements of the regulatory authorities.
  • To review and release batches to market in a timely manner so as not to cause stock outs.
  • To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and document review to ensure compliance with the requirements of the regulatory authorities. (Audit, Investigations, Change Control and Deviations permit release of batches to market.)
  • To liaise with the relevant Health Authorities in accordance with the Teva Notification to Management process.
  • To ensure appropriate audits, self-inspections and spot checks are carried out by trained and experienced staff.
  • To support Health Authority and Third party audits of the Eastbourne site.
  • To provide guidance and support for the Eastbourne packaging operations.