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Responsible Person (RP), GDP Pharmaceutical

Job Title: Responsible Person (RP), GDP Pharmaceutical
Contract Type: Permanent
Location: Bolton, Greater Manchester
Industry:
Salary: £50000 - £60000 per annum
Reference: J906261_1600938690
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Job Published: September 24, 2020 10:11

Job Description

Responsible Person (RP), GDP Pharmaceutical

Location: - Bolton/ Wigan area (SITE BASED) Salary: - £50,000 - £60,000 Depending on experience

Our Client, a leading Pharmaceutical / distribution outfit are expanding and looking to bring in a new GDP - RP for their modern site in Wigan.

The successful applicant will be responsible for ensuring GDP is adhered to throughout business operations. The company is currently going through a period of development and needs someone with a track record of managing change to ensure the QMS is tailored to the business, staff have appropriate training and the company complies with all GDP and Home Office requirements.

The Role:

  • All duties as set out in the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and the Human Medicines Regulations 2012.
  • Carrying out management reviews and self-inspections independently.
  • Implementing and maintaining a suitable QMS.
  • Promoting, encouraging, and driving continuous improvement throughout the business.
  • Effectively training staff at all levels on GDP criteria and requirements.
  • Applying for variations on the PCL portal when required.
  • Auditing third parties as necessary.

The Person:

  • A life science, pharmacy, or other relevant scientific degree
  • Worked as an RP within the past two years (with an MHRA person number).
  • Experience or participation of MHRA inspections.
  • Experience of working with senior stakeholders.
  • Have a proven track record of maintaining a QMS.
  • Understanding of the FMD, including verification and decommissioning.
  • Experience of working within a manufacturing environment (desirable).
  • Hold an enhanced DBS check issued by Security Watchdog (desirable).
  • Have passed an accredited "Gold Standard" course within the past 2 years (desirable).
  • Understand requirements surrounding the export of pharmaceutical products (desirable, training can be provided for the right candidate).

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