Regional QP - Pharmaceutical

Job Title: Regional QP - Pharmaceutical
Contract Type: Permanent
Location: Hertfordshire, England
Salary: Negotiable
Reference: J898324_1545305838
Contact Name: Tom Hammond
Contact Email:
Job Published: December 20, 2018 11:37

Job Description

Regional QP - Pharmaceutical

Location: Hertfordshire

Type: Permanent

Salary: Highly competitive, plus additional benefits

Travel: Limited, around 10%

Hours: Days

Our Client, a Global Pharmaceutical company are looking to recruit for an experienced QP / Regional QP who will work as a vital part of the Quality/ RA team and in return will be rewarded with a competitive salary plus additional benefits with expanded quality experience.

The Role:

  • To carry out the duties and responsibilities of a Qualified Person as detailed in EU Directive 2001/83/EC
  • To ensure the principles and responsibilities of GMP / GMDP, as stated in Directive 2003/94/EC and interpreted in the EU Guide to GMP have been followed and perform the duties of the responsible person as per MHRA
  • and EU regulations (2013/C 34301).
  • The review of batch documentation for pharmaceutical products and subsequent batch disposition, including certification for release
  • Sampling, inspection, batch processing and approval of bought-in products
  • Liaison with contract laboratories and review of data generated following analysis
  • Review of data generated by temperature monitoring equipment received with deliveries
  • Investigations into customer complaints
  • Management of recalls of pharmaceutical products for the market
  • Internal and external inspection programmes and to represent the department during regulatory inspections
  • Review and processing of expired inventory, returns and rejects
  • Maintain communication with third party warehouse, suppliers and line management.

The Person:

  • MUST BE a UK registered Qualified Person (essential)
  • BSc in Pharmacy or related science
  • Solid experience working within Quality Assurance
  • Experience of Analytical Method Transfers
  • Experience of new product introductions / transfer of QP release activities
  • Experience liaising with the MHRA
  • Have an understanding of pharmaceutical Quality Management Systems relevant to complaints handlingand investigations
  • Experience using SAP, Trackwise and Documentum

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