Job Ref: 215018859

Date: 2021-10-28 09:42:43

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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 (Apply online only)).
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 subjectPreferable

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 subjectCompetencies

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.
TenacityWork 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

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