QC Validation Specialist – £300-380 per day
Our client a Biotech company, based in Speke is looking for a QC Validation Specialist to join their growing team.
Reporting to a Validation Manager, the role holder will consult with and receive guidance and direction from the Senior Validation Manager and Validation Managers in order to interpret strategy. They will write and execute validation studies and operate within the confines of industry standards, EC directives, cGMP, regulatory directives, product licenses and company policies and procedures
This is a temporary role for 6 months (possibly longer) to start on 11th January 2021.
- Delivery of validation activities adhering to production schedule and project requirements
- 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.
- Co-ordinate the validation activities within the production facilities at Liverpool to ensure that the appropriate site and regulatory standards are applied, and work is completed in a timely manner
- Delivery of performance measures and validation compliance in line with Quality and HSE regulatory standards (RFT >80%, HSE targets, DR/CAPA/CC on time closure)
- Operate within the required standards of HSE, company Quality Systems and policies in accordance with Orange Guide, EU and CFR regulations.
- Maintaining training compliance >98%
- Perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.
- 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.
- 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.
- Educated to graduate level in a scientific discipline or equivalent
- Strong cGMP background in the Biological or Pharmaceutical industry
- Experience of sterile manufacturing
- Experience in the validation of QC Laboratory equipment.
- Preference for knowledge in the validation QC facilities and utilities.
- Previous experience of QC equipment validation is required.
- Previous experience of generating and executing IQ, OQ, PQ on GMP equipment.
- Exposure to CSV and IT systems is desirable.
- Experience of QC testing techniques and industry practices is desirable, to include Biological and Chemistry testing