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Qualified Person / QP - Pharmaceutical

Job LocationManchester
EducationNot Mentioned
Salary80,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

We are currently supporting our Pharmaceutical client in the Manchester area with hiring a permanent Qualified Person / QP to join their business, to support with continued growth.The business:The Qualified Person / QP will be joining a business at the coalface of the industry, playing a hugely important role in the supply of a range of key pharmaceutical products to the market.The business is embarking on a change programme geared around longer term growth and are looking for individuals who have the ability to play an active role in driving the business forward.The role:The Qualified Person / QP will be responsible for performing QP batch release and support with the day-to-day operation of the Quality Management System. Perform QP batch certification and meet QP duties as per GMP Annex 16. Work closely with the QA teamto ensure effective functioning of the Pharmaceutical Quality System.Some of the key responsibilities for the Qualified Person / QP will role involve the following:

  • Undertaking and performing all Qualified Person (QP) activities ensuring adherence to the sites Manufacturing Licence (MIA) and PLPI Marketing Authorisations.
  • To undertake routine product certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (EudraLex volume 4)
  • Assist and lead in maintaining GMP & GDP standards across all site operations
  • Timely QP certification for release of all products
  • Support deviations, CAPA, change control, complaints, recalls, risk assessments, re-works and adverse events
  • Reviewing and approving Standard Operating Procedures and other relevant GMP documents relating to the manufacture, labelling and assembly operation, storage, and distribution of medicinal products.
  • Advise Senior Management if there are any significant GMP compliance risks Ensuring the business are meeting cGMP requirements relevant to this industry e.g. Data Integrity, FMD/safety features.
The ideal candidate for the Qualified Person / QP role will have the following background:
  • An Eligible Qualified Person / QP who has performed product release
  • Extensive industry experience within the Pharmaceutical sector (experience across a range of dosage forms and product categories).
  • Degree qualified in a Scientific discipline, and ideally have evidence of continual professional development throughout career
  • Auditing experience is a must.
  • A natural leader who likes taking responsibility and driving a quality culture across a business.
Keywords: Qualified Person, QP, Head of Quality, Quality Director, Pharmaceutical

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