Support the equipment used in the QC Section. Ensure equipment is and stays correctly specified, validated and calibrated for use in a GMP regulated environment. Provide hands on assistance during validation exercises carried out by the Validation department.
MAIN DUTIES AND RESPONSIBILITIES
- Specify new QC equipment and ensure current equipment remains suitably specified in collaboration with users
- Ensure that equipment is appropriately validated and calibrated for GMP use in collaboration with the Validation department.
- Write procedures for new equipment and update procedures for current equipment as necessary.
- Provide hands on assistance to the Validation team ensuring that equipment validation is carried out in a suitable time frame.
- Interact with equipment suppliers to keep equipment up to date, ensure that equipment stays compliant, ensure PBL has the most suitable equipment and ensure repairs when necessary are made suitably.
- Assist with the evaluation of potential new equipment.
- Keep GMP records of equipment up to date.
- Ensure equipment within QC is consistently audit ready.
- Assist with the safety assessments for QC equipment.
- Produce and review GMP documentation as required for example SOPs, Protocols and Reports
- Carry out training of QC staff in the use of new equipment.
- Maintain an up-to-date awareness of regulatory and scientific developments via courses, meetings and literature.
- Degree in Biological Science or Chemistry or Biochemistry
KNOWLEDGE AND EXPERIENCE
- Good working knowledge and experience of cGMP
- Good working knowledge and experience of Analytical and QC equipment
- Good understanding of 21 CFR part 11 compliance associated with QC equipment
- A clear understanding of data integrity
- Knowledge of and practical experience in the specifying of QC equipment
- Knowledge of and practical experience in validating QC equipment
- Knowledge of and experience in troubleshooting problems with QC equipment
SKILLS AND CAPABILITIES
- Ability to use technical software packages
- Able to logically troubleshoot and discuss data with engineers
- Able to apply theoretical knowledge to practical situations
PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / EQUIPMENT / PHARMACEUTICAL PRODUCTION / PROCESS DEVELOPMENT / ANALYTICAL DEVELOPMENT / QUALITY CONTROL / QUALITY ASSURANCE / GMP / SUPERVISOR / TECHNICAL FILES / TECHNICAL DOCUMENTATION / ICH GUIDELINES / SOFTWARE / cGMPs / METHODS / ESSAYS / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / ADAPTING / TECHNOLOGIES / PBL / IDENTIFYING / ADAPTING