Quality Assurance Officer

Guy's and St Thomas' NHS Foundation Trust; London; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading healthcare organization is seeking a GMP Specialist to maintain compliance with Good Manufacturing Practices within their Advanced Therapies Manufacturing Unit. This role involves oversight of production and quality control activities, training staff, and making informed decisions to ensure regulatory standards are met. Candidates must possess specialized knowledge in GMP and be prepared to handle complex quality system requirements.

Qualifications

• Specialist knowledge in GMP practices required.
• Experience with regulatory compliance and quality systems.
• Ability to make informed decisions in production scenarios.

Responsibilities

• Ensure compliance with GMP and maintain quality standards.
• Manage production and quality control activities unsupervised.
• Provide supervision and training for staff.

Skills

Good Manufacturing Practice

Quality Control

Six-Sigma analysis

Deviation Management

Production Environment Monitoring

Education

Degree in a relevant scientific discipline

Job description

Working under the trusts Pharmaceutical Quality System, the post holder will use their specialist knowledge in Good Manufacturing Practice (GMP) to maintain compliance with regulatory standards and drive continuous improvement.

The job will include review and oversight of activities undertaken in both Production and Quality Control groups within the ATMP manufacturing unit, and the preparation of records for authorisation. Deviation management is a key component, using specialist knowledge to develop informed and reasoned decisions regarding the disposition of products and tests.

• You will ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment.
• Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained. Provide trending data used to set alert limits for monitoring control of the environment.
• Undertake product quality review to ensure that specifications for products are under control, using Six-Sigma analysis, and provide solutions to gain further control where necessary.
• Work unsupervised managing production and analytical deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production.
• Provide day-to-day professional supervision and practical training for production and quality control activities and ongoing supervision of support staff, and new and junior staff.
  
  

The Advanced Therapies Manufacturing Unit (ATU) is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15th floor of the tower. The ATU is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials or as Specials. It is used for both commercial and non-commercial collaborators as well as departments within GSTT to manufacture ATMPs related to trials undertaken in the CRF and at trial sites across the UK.

For further details / informal visits contact: Name: Sakina Gooljar Job title: Head of Advanced Therapies Quality Email address: [e-mail] Telephone number: 02071887188

Telephone Extension 56097