SRG are currently looking to recruit for a process operator to join a Global Biotechnology company based in the Liverpool area. This organisation focus on therapeutic proteins, monoclonal antibodies and other next generation molecules to attach a wide range of disease...
Job Title: QC Validation Analyst
Location: North West UK
Job Type: Temporary
A leading healthcare pharmaceutical organisation is currently looking for a QC Validation Analyst to co-ordinate the activities of validation work; specifically manage the validation activities of testing methodology and equipment within the QC laboratories, in terms of project management, protocol writing and executing or completion of final validation reports.
The role holder is responsible for but not limited to the following activities:
- To operate within the required standards of HSE, company Quality Systems and policies in accordance with Orange Guide, EU and CFR regulations.
- To perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.
- To write and execute validation protocols following ICH guidelines and other organisational standards; to promptly write reports on completion of execution of the validation/verification studies.
- The role holder will be required to participate in planning and execution of projects including monitoring ongoing validation exercises and providing regular updates on progress, communicating possible issues that may affect timelines and milestones.
- To participate in laboratory administration, including notification of out of specification, deviations initiation/investigation, PPA, progression of change controls related actions, SOP reviews and closure of assigned corrective/preventative actions.
- To ensure that the maintenance, qualification and calibration of laboratory equipment used is up to date and at the required GMP standards and to participate in method/instrument troubleshooting.
- Effective communication both written and oral on a daily basis with colleagues at all levels, to include liaison with QA and Operational/Team managers.
- To maintain responsibility for upkeep of own training records and to operate within the scope of trained activities.
- Maintain work activities to meet requirements and maintain healthy, safe and productive working conditions.
It is essential that the successful QC Validation Analyst should have strong cGMP background in the Biological or Pharmaceutical industry. Experience of QC testing techniques and industry practices, to include Biological and Chemistry testing is essential. Awareness or previous experience of method and equipment validation is preferable but not essential.
If you are looking to work with a world-class pharmaceutical development and manufacturing organisation on life changing vaccines, please apply online or send your CV directly to Behruz Sheikh on . If you have any questions, please contact Behruz Sheikh directly on 0161 868 2202.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.