QA Director and Responsible Pharmacist

  • Full-time

Company Description

MedSupply UK (an International SOS company) is a leading supplier of pharmaceuticals, surgical and medical equipment, medical consumables and first-aid supplies worldwide. We have the ability to source and supply high quality products from manufacturers worldwide and dispatch using the most economical and reliable methods available.

Job Description

We are currently recruiting a QA Director and Responsible Pharmacist to join our team in Barking, East London. Responsible for ensuring that the services provided by the site is fit for purpose, maintaining and continually improving the company’s Quality Management System, and providing regulatory and pharmaceutical advice.

Key Responsibilities

  • Act as the ‘Responsible Person’ on WDA and take on such duties as stated in the latest edition of ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’ compiled by the MHRA.
  • Ensure that the guidelines on GDP and GMP (under the directions of the contracted QP) are complied with as relevant to activities under MIA.
  • Support the production team in the production (GMP Labelling) facility.
  • Assist in ensuring that the operations do not compromise the quality of medicines.
  • To ensure full and prompt cooperation with marketing authorisation holders in the event of recalls.
  • Ensure all complaints, deviations, failure investigations are documented, investigated for root cause and applicable corrective and preventative actions are implemented.
  • Ensure all change controls are documented and disposed in a compliant manner. All risks are identified and risk management principles are applied to control risks.
  • Ensure that the licenses issued by the UK Home Office for the handling of Controlled drugs are maintained according to the relevant regulations.
  • Act as the ‘Person responsible for Quality Controls’ as stated in the MHRA regulation for Manufacturer’s Licence holders.
  • Ensure all complaints, deviations, failure investigations are documented, investigated for root cause and applicable corrective and preventative actions are implemented.
  • Ensure that the licenses issued by the UK Home Office for the handling of Controlled drugs are maintained according to the relevant regulations.
  • Ensure the computer systems used in GMP GDP functions are adequately qualified and maintained to ensure regulatory compliance.
  • Act as site liaison for regulatory and client audits as related to GMP and GDP.

Qualifications

Required Experience & Skills

  • Extensive experience within the  pharmaceutical wholesale and/or manufacturing industry.
  • Related experience in dealing with UK regulatory and licensing authorities within the pharmaceutical industry.
  • Experience as a Responsible Person within the pharmaceutical industry.
  • Experience of QA Lead within the pharmaceutical industry.
  • Work history within the QHSE environment or an appreciation of the requirements desirable.
  • Understanding of the Commercial Maritime and/or Aviation industry standards and regulations is a plus.
  • Experience with GS1 and serialisation desirable.
  • Multinational management exposure preferred.

Additional Information

Diversity & Collaboration

Our company brings together remarkable people and enables them to be themselves.

At International SOS, we offer a great working environment, thanks to our commitment to a flexible working environment, diversity, and development.

We celebrate diversity on a global scale. We encourage every colleague to bring their personal best by creating an environment of inclusion and equal support.

Our success is the result of diverse ideas, skills, and cross-cultural understanding.

www.internationalsos.com

www.medsupply.com 

International SOS has been recognised as a Top Employer in the UK by the Top Employer’s Institute (TEI) for 2021

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