Senior QA Manager - RPi

Location Marlow
Discipline: Pharmaceutical
Job type: Permanent
Salary: £Negotiable
Contact name: Liam Smith

Contact email: admin@superadmin.sciencesr
Job ref: BBBH3026_1635410561
Published: about 1 month ago
Startdate: ASAP

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.