Qualified Person - QP

£0.00 - £90000.00 per annum
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United Kingdom
Hatfield, Hertfordshire
Posting date: 29 Mar 2019
QA.KM.22453_1553862376

ProClinical is with a well-known international pharmaceutical company to advertise a vacancy for a Qualified Person position. The company specialises invarious therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. Based in Hatfield, this is an exciting opportunity to work with a prestigious and innovative organisation.

The Qualified Person will support the Quality Operations Senior Director EMEA in the implementation and maintenance of EML's Quality Assurance activities relating to product support used for the manufacture, packaging, testing, storage and distribution of marketed products. They will also ensure that operations are compliant with current GMP and company corporate expectations, along with enhancing quality policies, systems, and procedures.

Job Responsibilities:

  • Reviewing and disposing batches for marketed products in accordance with the UK Code of Practice for Qualified Persons on behalf of all EML QPs.
  • Performing QA reviews and approving master and executed batch records and associated documents.
  • Supporting the ongoing compliance of the EML facility, including implementing new GMP requirements, raising initiatives to improve compliance with current GMPs, and training, coaching, and mentoring EML staff in GMP and compliance.
  • Writing, reviewing, and approving SOPs.
  • Participating in the execution of the internal and external audit process according to the audit schedules.
  • Supporting the Quality Operations Senior Director EMEA in the preparation and management of third-party audits and competent authority inspections.
  • Reviewing and approving Quality Agreements and Product Quality Reviews.
  • Reviewing and approving deviations and customer complaints and supporting with their associated investigations and CAPAs.
  • Assessing change controls.
  • Reviewing and approving qualification/validation protocols and reports.
  • Participating in the testing of EML's EU product recall procedures on an annual basis or product recall.
  • Supporting and leading EML projects where required.
  • Initiating and supporting EML continuous improvements.
  • Supporting EML management review meetings.
  • Attending QO management meetings.
  • Performing any appropriate duties at the request of the Quality Operations Senior Director EMEA and deputising for them when appropriate.

Skills and Requirements:

  • A Bachelor's degree.
  • Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines, and an understanding of the manufacture and packaging of pharmaceutical products.
  • Good technical and scientific judgement.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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