Hyper Recruitment Solutions are currently looking for a CSV Specialist to join a Pharmaceutical company on a 12 month contract in a fully remote working role. The role sits outside of IR-35.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Engineer will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for the implementation of a risk-based approach to the validation of computerised systems in accordance with EU GMP Annex 11, 15 and GAMP 5, whilst ensuring compliance with the company QMS and ensuring the validation status of computer systems are compliant with cGMP.
2. As the Interim CSV Specialist, you will be responsible for working on the full validation life cycle of lab systems and IT systems.
4. You will provide project teams with expert computerised system validation guidance and definition of appropriate CSV strategies and also train other staff members on the correct use of computerised systems in line with protocols and regulations.
To be successful in your application to this exciting opportunity as the CSV Engineer we are looking to identify the following on your profile and past history:
1. Relevant Degree in Life Science, Engineering or Computer Science and proven industry experience in computer systems within the pharmaceutical industry is essential for this role.
2. Good knowledge of GAMP5 guide and previous CSV experience within a Pharmaceutical company.
3. Additionally, as the CSV Engineer, you will also need to have had experience managing and documenting validation processes.