Are you looking to move your career into Computer Systems Validation? If so, we have a fantastic opportunity for a CSV Officer to join a global pharmaceutical business based in West Yorkshire.
As the CSV Officer you will primarily be responsible for the development and execution of qualification and validation packages, test scripts and protocols.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Officer will be varied however the key duties and responsibilities are as follows:
1. To implement cGMP, MHRA and FDA requirements across IT GxP systems and to ensure compliance to these and current best practices. Write, approve and/or support Policies and Procedures regarding computerised systems and ensure adherence to these and other related Policies.
2. Write and execute system validation documentation including; Risk Assessments, FDS VAP, URS, UAT, IQ/OQ and PQ. Review and maintain the Site Validation Master Plan.
3. Provide CSV advice and recommendations to stakeholders as required. Participate in activities/projects as CSV subject matter expert. You will also be required to support internal and external auditors, such as the MHRA or FDA.
4. Management of the validation life cycle of IT manufacturing business systems including:
a. Environmental monitoring systems
b. Serialisation and decommissioning systems relating to the Falsified Medicines Directive
c. Systems supporting manufacturing and packaging operations
To be successful in your application to this exciting opportunity as the CSV Officer we are looking to identify the following on your profile and past history:
1. You will be degree qualified in a relevant Scientific, IT or Engineering discipline and have a good understanding of Computer Systems Validation.
2. The successful candidate will have a broad range of knowledge in systems/applications relevant to pharmaceutical manufacturing or a similar highly regulated manufacturing environment, such as Medical Devices or Life Sciences. A knowledge of cGMP would be beneficial.
3. A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT hardware, software architecture and IT infrastructure concepts is essential.
Key Words: Computer Systems Validation | CSV | Validation | Pharmaceutical | cGMP | Quality | GxP | IT
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.