J563251WiltshirePharmaceutical Biotechnology Engineering Permanent£40,000 to £63,000 per annum - Dependent on Experience Full Time01/04/2019Quality Assurance - Validation Quality Assurance – GMP Engineering – Validation Quality Assurance – CSV
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We are currently looking for a Computer System Validation (CSV) Manager to join a leading company based in the Wiltshire area. As the Computer System Validation (CSV) Manager you will be responsible for managing the regulatory cGMP compliance of computerised and software systems, ensuring that they are appropriately qualified and fit for operational use.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Computer System Validation (CSV) Manager will be varied however the key duties and responsibilities are as follows:
1. You will be the site lead on Computer System Validation activities communicating regulatory issues and business risks to senior management together with recommended actions.
2. You will lead and manage a team of Validation Specialists to deliver general computerised equipment validation projects on time and in line with regulatory requirements.
3. As the Computer System Validation (CSV) Manager, you will take responsibility for the management of validation and on-going re-qualification strategy for all regulated computer systems on site.
4. You will be the organisations expert on CSV and represent the company during internal and external audits.
To be successful in your application to this exciting opportunity as the Computer System Validation (CSV) Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science, Computer Science or Engineering related discipline, or equivalent.
2. Proven industry experience in generating site wide validation policies and strategies to comply with GxP regulations and to mitigate business risk. You will also need experience in leading and managing validation activities and staff.
3. A working knowledge and practical experience with validating large systems, including PLCs, SCADA, EQMS, Networked Systems, laboratory Systems and layered software used in a GxP environment.
Key Words: Computer System Validation | CSV | Manager | Validation | Pharmaceutical | Manufacturing | PLC | SCADA | Development | Production | EQMS | Network Systems |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.