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.
- Sitting for extended periods of time.
- Ability to work under own initiative and as part of a team.
