Up to £700 per day, DOE
about 1 month ago
We are currently working with a leading Biotech organisation who are looking to hire a QA Consultant on an initial 6 month contract, to work in their Edinburgh office to manage and be responsible a number of products they have ongoing at the moment.
- To ensure that the key elements of the Quality Management System relating to GxP are effectively implemented in order to ensure that the company is operating in compliance with GxP regulations.
- To ensure that there is an appropriate level of QA involvement in the project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
- To ensure that Technical (Quality) Agreements are established and maintained for all third party contractors and that activities relating to content e.g. batch release, process deviations, stability testing, change control, Product Quality reviews etc. are implemented meeting GxP requirements.
- To ensure that there is an appropriate level of QA review and approval of validation protocols and reports during Technical Transfer and process change activities in order to ensure that manufacturing processes and analytical procedures at the CMOs operate in a validated state.
- To ensure that internal (self-inspection) and external GxP audits of Contract Manufacturing Organisations (CMOs) and Contract Research Organisations (CROs) are carried out, and followed up, at appropriate intervals in order to monitor compliance with GxP regulations and to identify non-compliance issues for corrective and preventative actions
- Experienced within Quality Assurance in a Biologics environment is a must.
- Extensive experience with QMS
- Previous background of carrying out and being responsible for internal and external audits.