Salary: circa 25-32k
Dept.: GMP Production.
Reports to: Interim Director of Production.
We are looking for applicants that hold a relevant degree (or equivalent), demonstrate a thorough understanding of quality systems associated with GMP manufacture, have a sound understanding of GMP compliance and have previously held a supervisory or management position within a pharmaceutical production environment.
To provide technical expertise towards, and take responsibility for, the integration of novel and new technologies into existing processes, and to take a lead in trouble shooting of existing processes when required.
MAIN DUTIES AND RESPONSIBILITIES:
- Act as the key Production representative, and take responsibility for, the adoption of new products into new and existing production areas.
- Act as the key Production representative on project teams set up to source, validate, and introduce new technologies, equipment, and processes into production processes.
- Take the lead in the generation of new process/equipment documentation (URS, SOPs) required to ensure the novel and new technologies/equipment is brought into beneficial use in a compliant and timely manner.
- Responsible for the compliant transfer of novel and new technologies and equipment into existing processes.
- Lead the training required for process staff to be able to understand and use novel and new technologies in a compliant manner.
- Provide technical and specialist support
Degree in a biological sciences or engineering discipline, or significant relevant experience.
Significant relevant work experience in a GMP regulated environment.
Significant work experience and knowledge of pharmaceutical Quality Assurance and GMP documentation.
Previous experience of preparing documents required for operation of a regulated biopharmaceutical manufacturing facility.
Extensive working knowledge of production operations carried out to GMP standard.
Understanding of the regulatory requirements for validation and operation of pharmaceutical equipment.
Working knowledge of equipment and computer validation requirements.
Understanding of Data Protection legislation.
COMPLIANCE / DOCUMENTATION / TECHNICAL / PRODUCTION / ENGINEERING / GMP / SUPPORT / TECH TRAMSFER / TECHNOLOGY TRANSFER / QA OFFICER / QA SCIENTIST / QA CHEMIST / BIOCHEMICAL / BIOTECHNOLOGY / BIOTECHNOLOGIST / BIOCHEMISTRY / QC / QA / GMP / BIOPHARM / BIOPHARMACEUTICAL / MANUFACTURING / PROCESS DEVELOPMENT / DOWNSTREAM / UP STREAM / VALIDATION / PURIFICATION / PROTEIN / PROTEIN CHARACTERISATION / QUALITY CONTROL / QUALITY ASSURANCE / GMP / GXP / MICROBIOLOGY / MICROBIOLOGIST / SCIENTIST / SCIENTIFIC / DRUG / PHARMA / PHARMACEUTICAL / BIOTECH / BIOTECHNOLOGY / QC / BIOPHARM / BIOPHARMACEUTICAL / BIOLOGICAL / BIOCHEMICAL / CLINICAL / TECHNICAL / OFFICER / EXECUTIVE / WILTSHIRE / SW ENGLAND / SOUTH WEST / UK / UNITED KINGDOM / QC SCIENTIST / QC CONTROL / QC ANALYST / QC CHEMIST / CHEMISTRY / BIOCHEMISTRY / BIOCHEMIST / UK / UNITED KINGSOM / SOUTH / SW / SOUTH WEST / BRISTOL / OXFORD / WILTSHIRE / OXFORDSHIRE / HAMPSHIRE / BASINGSTOKE / SURREY / BERKSHIRE / READING / MAIDENHEAD / M3 / M4 / MIDDLESEX / MSD / MERCK / HOUNSLOW / LONDON / SOUTHAMPTON / SOMERSET / DEVON / SOUTH WEST ENGLAND / TECHNICAL / DOCUMENTATION / SOP’s