Senior Quality Manager (RPi)

BAP Pharma
Marlow, Buckinghamshire (GB)
Competitive base salary + performance based bonus
29 Sep 2021
29 Oct 2021
BAPQMUK
Quality, QA / QC
Full Time
Permanent
Experienced (non-manager)

Company

Come and join us!!

BAP Pharma is a global leader and still the fastest growing company involved in the supply, packaging and labelling of medicines used in ground-breaking clinical trials. Now in our 10th year of trading, we’re set to beat our targeted turnover of €250M in 2021, with more growth to come. We have grown on average at 45% per year in each of the last 2 years. And to maintain our growth, we have invested significantly in new sites globally. Currently moving to state-of-the-art new facilities in both UK and USA and a recently establish EU facility in Germany. Come and join the team, develop your skills, and grow as our exciting, development and expansion continues. We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!

Job Description

BAP have an amazing opportunity for a Senior Quality Manager and act as our RPi. The Senior Quality Manager's role is to ensure that BAP Pharma is compliant with MHRA guidelines concerning medicines & Home Office guidelines for Controlled Drugs.

The Senior Quality Manager is responsible for safeguarding product users against potential hazards arising from poor distribution practices and to be knowledgeable of UK and EU legislation.

Job Requirements

Essential

  • Eligible Responsible Person in accordance with EU Directive 2001/83/EC
  • Knowledge of Eudralex, The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use.
  • Good Understanding of the Wholesale Dealer’s Licence.
  • Knowledge of The Human Medicines Regulations (UK SI 2012 1916).
  • Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use.
  • Understanding of, The New Guidelines for Good Distribution Practice of medicinal products for human use.
  • Knowledge of Commission guidelines for GDP of medicinal products for human use (2013/C 68/01).
  • BSc in Pharmacy, Chemistry, Biology, or related subject

Preferable

  • Experience with either Comparator Sourcing, Clinical Packaging & labelling or Unlicensed Medicines
  • Familiarity with I.T programmes such as; eQMS, ERP, WMS and FMD systems
  • Supported QP release of IMP and/or unlicensed medicinal products
  • Lead Quality Teams
  • Experience in hosting supplier/ client audits and regulatory audits such as MHRA
  • MSc in Pharmacy, Chemistry, Biology, or related subject

Competencies

  • Attention to Detail and Thoroughness.
  • Concern for Standards.
  • Excellent communication skills.
  • Diplomacy with MHRA, Home Office and Clients.
  • Interpersonal awareness and sensitivity.
  • Flexibility and Adaptability.
  • Tenacity

Work Conditions

  • Reports directly to the Managing Director.
  • From time-to-time overtime may be required to meet project deadlines.
  • Ability to work under own initiative and as part of a team.