SALARY: Circa 25-32k
We are looking for an effective candidate educated to degree level or equivalent to review the investigations and provide advice to ensure the resolution of the non-conformances and the implementations of timely CAPAs.
In addition, the post holder will provide training/advice to staff for the use of the electronic management system.
The post holder will report to the Senior Compliance Officer and will have excellent proven interpersonal and organisational skills
- To negotiate corrective and preventive actions necessary to achieve compliance.
- To investigate Quality compliance issues within GMP areas and prepare associated reports.
- To support the continuous improvement of procedures related to the non-conformance and CAPA system.
- To provide training and troubleshooting support to relevant staff for the operation of the electronic non-conformance system.
- To participate in staff GMP training.
- To provide technical and compliance advice (Quality oversight) to project teams.
- To keep up to date with regulatory requirements and technical advances.
- In line with overall responsibilities, to perform other tasks assigned or objectives set by Line Management.
- To undertake work in accordance with the Health and Safety policies and procedures and to work within any Quality Systems that are applicable to the site.
Educated to degree level or HND in relevant subject (e.g. Microbiology, or a related subject) or a demonstrable equivalent level of experience of working at a similar level in specialist area
Experience in operating quality system(s) in a GMP QA environment with proven evidence of encountering a wide range situations.
Proven experience in operating a GMP non-conformance system in a QA environment in a wide range of situations..
Practical experience in GMP Biopharmaceutical manufacture, testing or engineering, with proven evidence of encountering a wide range of situations.
Extensive experience of using an eQMS system in a QA environment.
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
- Quality Assurance