This post is part of a team within the Immno Manufacturing unit. The unit is an MHRA licensed facility consisting of several GMP cleanrooms. The successful applicant will be directly responsible for the manufacture of the UK’s only Anthrax Vaccine.
Day to day tasks will also include preparation of reagents and equipment as well as cleaning and maintaining the facility to the high standards required for the production of pharmaceutical product.
MAIN DUTIES AND RESPONSIBILITIES
- Perform a range of routine Production and some non-routine technical procedures and understand the rationale behind the procedures and practices.
- Supervise and support junior staff in daily activities.
- Ensuring other staff members are adequately trained in all operational processes.
- Responsible to the unit supervisor and able to deputise in their absence. Undertake all work in accordance with HPA’s Code of Safety Practice, QualitySystem ?and all other regulatory requirements.
- Follow defined procedures, policies, rules, regulations and guidelines for all activities ?to ensure product meets the required standard.
- Generate and review documentation with regard to Risk Assessments and cGMP to ?ensure compliance of the unit with all necessary regulations.
- Work diligently at all times. Complete documentation and records accurately and to a ?high standard.
- Ensure the unit is maintained in a compliant state. Work to cGMP following Standard ?Operating Procedures (SOPs) and Codes of Practice. Keep updated on new rules and? regulations.
- Maintain production areas to the required standard using defined cleaning procedures. Perform and record environmental monitoring and water sampling in cGMP areas in ?accordance with documented procedures. Monitor and record air pressures and hot and cold facility temperatures.
- Analyse information and make decisions based on assessment.
- Assist validation department with validation protocols on equipment.
- Maintain and use a variety of laboratory equipment.
- Work with a range of hazardous and non-hazardous chemicals.
- Be competent in and perform aseptic techniques.
- Be qualified to work in a clean room environment and in containment level 3 suites.
- Work accurately and with good hand eye co-ordination, sometimes for prolonged periods of time.
- Operate autoclaves and sterilising ovens and have an appropriate level of understanding to review cycle data as a senior operator.
- GCSE (grades A-C) in Maths, English and Science
- Two A Levels or equivalent or prior experience in a relevant industry
KNOWLEDGE AND EXPERIENCE
- Experience of working to GM guidelines
- Experience in working in a cleanroom environment or relevant industry
SKILLS AND CAPABILITIES
- Knowledge of cGMP requirements and how to implement them
- Accurate and clear record keeping
- Ability to follow established written procedures
- Experience with operation and adjustment of specialised equipment
- Understanding of various relevant regulatory requirements
- Understanding/ knowledge of cleanroom and GMP procedures
PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / EQUIPMENT / PHARMACEUTICAL PRODUCTION / MAINTENANCE / CONSUMABLES / QUALITY CONTROL / ENVIRONMENTAL / GMP / SUPERVISOR / TECHNICAL / TECHNICAL DOCUMENTATION / FPP / CLEANING / cGMP / METHODS / SAMPLES / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / MATERIALS / TECHNOLOGIES / PBL / ADAPTING / POLICIES / PROCEDURES / MANUFACTURING / RISK ASSESSMENTS / REGULATORY / EQUIPMENT / CHEMICALS / RECORD KEEPING / STERILISING
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