Regulatory Compliance Officer

6 days ago

London, Greater London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

About the Role

We are seeking an experienced Pharmaceutical Quality Assurance Specialist to join our team at Guy's and St Thomas' NHS Foundation Trust. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing and quality control units.

Key Responsibilities

  • Lead and deliver Pharmaceutical QA Services to the Trust Pharmacy Manufacturing and Quality Control Units.
  • Be responsible for maintaining the integrated Quality Systems across the Pharmacy Manufacturing Service as required by the MS, MA(IMP) licences and NHS guidance.
  • Act as a Releasing Officer for any unlicensed products received into the Trust as required.
  • Provide technical support and advice on QA to other departments in the Trust and to external customers of the Trust.

Person Specification

  • Pharmacy degree or Masters degree in science based discipline.
  • Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge.

Desirable Qualifications and Experience

  • Member of professional society/institution (Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society).
  • Previous evaluated experience working as a releasing officer in a licenced/unlicensed pharmaceutical production unit with a comprehensive portfolio of products.
  • Experience of quality systems and documentation management systems.

Key Skills and Abilities

  • Demonstrated practical knowledge of GMP, QA, risk management and all current relevant regulations.
  • Demonstrated ability to identify and manage risks.
  • Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
  • Demonstrated computer and IT skills including databases & pharmacy specific systems for building and managing products.'

About Us

Guy's and St Thomas' NHS Foundation Trust is among the UK's busiest and most successful NHS Foundation Trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopedic, respiratory and cardiovascular services.

Guy's & St Thomas' Technical Services is a large licensed and section 10 manufacturing unit with a wide product portfolio, including terminally sterilised, aseptically manufactured and non-sterile products, as well as a variety of extemporaneously prepared aseptic and non-sterile dosage forms. Pharmacy Technical Services employs over 100 staff in multiple areas across the Guy's and St Thomas' sites.

Pharmacy Quality Assurance provides QA support to a number of facilities across both the Guy's and St Thomas' sites, including the MS licensed Aseptic, Sterile and Non-sterile Units and also unlicensed units (CIVAS/TPN and Oncology) and the main Pharmacy.

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