This role serves both Quality Control and Quality Assurance functions. The primary responsibility will be in the microbiology laboratory sampling, testing and reporting data. QA activities will involve administration end execution of internal control systems such as line clearances, internal audits etc. Also included in the role is responsibility for development and management of QA systems.
- Analysis of raw material, in process material and finished products as required.
- Sampling of materials, utilities and environment.
- Analysis of utilities and services i.e. water, air, environmental.
- Participate in method transfer, method development and validation s as required.
- Ensure that all testing equipment is cleaned, set-up and operated according to Standard Operating Procedures.
- Perform on-line machine adjustment and trouble-shooting where necessary.
- Review and assess results and action appropriately e.g. OOS, material Status, deviations, alarms etc.
- Managing consumables supply within the laboratory
- Development, maintenance and implementation of Quality Assurance system to ensure compliance with relevant regulatory requirements. Systems include
- In house auditing
- Exception and deviation management e.g. CAPA, Non-Conformance etc.
- Documentation review including Batch recordsSupporting quality aspects of materials management including line clearance, supplier approval, supplier complaints, and specification management.
- Qualification in science discipline at primary degree or diploma level. The Qualification must have a high microbiological content
- Experience in endotoxin analysis, bioburden analysis, and sterility would be an advantage. Basic techniques e.g. culture transfer, growth promotion are required
- Experience in Method validation and method transfer would be an advantage.
- Aptitude for and/or experience with computer literacy would be an advantage.
- Experience of scientific report writing including such documents as SOP's, protocols, deviations, reports etc.
- Ability to evaluate and access information to determine appropriate risk and required actions is critical
- Understanding of pharmacopeia requirements for pharmaceuticals
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.