A specialist pharmaceutical services company is seeking to appoint an additional Responsible Person to support its growing Quality and Regulatory function.
The organisation partners with healthcare professionals, pharmaceutical and biotech companies, as well as aid organisations and charities, to ensure global patient access to medicines across a wide range of supply routes.
Due to continued growth and expansion, the business is looking to strengthen its RP capability, working closely with an established RP team to ensure full compliance with GDP requirements and regulatory expectations.
The role will involve day-to-day use of an electronic Quality Management System, alongside internal systems, to monitor and assure compliance across a complex and international distribution network.
This opportunity would suit an experienced GDP Quality professional or Deputy RP looking to further develop within a technically complex pharmaceutical distribution environment.
Key Responsibilities
* Supporting oversight and maintenance of the Quality Management System in line with GDP requirements
* Monitoring compliance across distribution and supply activities
* Reviewing and maintaining quality documentation within the electronic QMS
* Supporting regulatory compliance across import, export and distribution activities
* Assisting with internal and external audits and inspections
* Supporting the RP team across multiple and varied supply models
Candidate Requirements
* Degree in a Life Science or related discipline
* Minimum 2 years’ experience within pharmaceutical wholesale / GDP environments
* Must meet MHRA eligibility criteria to act as a Responsible Person
* Demonstrable experience supporting or maintaining a QMS within the UK or Ireland
Desirable Experience
Experience in any of the below would be advantageous:
* Unlicensed medicines import and distribution (including Listed / non-Listed countries under an MS Licence)
* Distribution under Schedule 17 (e.g. supply to ships, aircraft, research organisations)
* Qualification of export customers in higher-risk or remote territories
* Ireland / HPRA regulatory exposure
* Customs documentation and export processes (e.g. CPCs, export declarations)
* Veterinary medicines distribution
* Import/export of medical devices and cosmetics
* Secondary packaging activities
* Controlled drugs distribution
Overview
This role offers the opportunity to work within a technically complex, internationally focused pharmaceutical services environment, supporting a diverse range of supply models and regulatory requirements.