To work as a member of a team involved in the fermentation and recovery operations of the Erwinase manufacturing process, working within cGMP/ISO 9001 Quality Systems.
MAIN DUTIES AND RESPONSIBILITIES
- To carry out duties involved in the manufacture of biopharmaceuticals to GMP and ISO 9001 requirements as directed.
- Ensure that the facility is maintained in a compliant state and that the product/materials are manufactured to appropriate regulatory requirements.
- To undertake all necessary training to enable the post holder to carry out his/her duties to the required standard.
- To undertake work in accordance with PBL Health and Safety Policies and procedures and to work within any Quality systems that are appropriate to the site.
- To comply with all PBL policies and procedures.
- In line with any other responsibilities, to perform any other tasks assigned by the Line Manager. ?
The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the directorate. The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation. ?
- GCSE (grades A-C) in Maths, English and Science
- Educated to minimum of NVQ level 2 in a relevant subject or equivalent level of qualification
KNOWLEDGE AND EXPERIENCE
- Working in a manufacturing environment
- Worked within a Quality system ( cGMP/ ISO)
- Previous experience of working in an administrative environment using computer data systems
SKILLS AND CAPABILITIES
- Clear communicator with good writing, data entry and telephone skills ensuring accuracy
- Flexible approach to work
- Problem solving skills
- To be able to work on your own initiative, organising and prioritising workload to set deadlines
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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