We are currently looking for a Computer Systems Validation (CSV) and Data Integrity Manager to join a leading Medical Devices Company.
As the CSV Manager you will be responsible for site Data Integrity coordinating systems validation project related activities, data management systems (LIMS, SCADA) and developing personnel.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Manager will be varied however the key duties and responsibilities are as follows:
1. You will develop the Computer Systems Validation approach and policies to guide the company to robust compliance in accordance with regulatory guidelines: 21 CFR Part 11, 21 CFR part 820, EU Annex 11 and GAMP.
2. You will use your extensive experience with IT Validation, Equipment Software Validation and Risk Management Processes to ensure systems are validated and robust.
3. As the CSV / Data Integrity Manager, you will play a key role in development of technical requirement specifications for future data management systems; LIMS, SCADA etc.
4. You will lead, coach and mentor both Trainee and experienced Computer Systems Validation (CSV) Specialists.
To be successful in your application to this exciting opportunity as the CSV Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in an IT, Data, or Scientific Discipline.
2. Proven industry experience in IT Validation, Computer Systems Validation, Equipment Software Validation in the Medical Devices, Pharmaceutical or Biotechnology industry.
3. A working knowledge and practical experience with LIMS, SCADA, and extensive knowledge of the regulatory expectations for Data Integrity with detailed knowledge of 21 CFR Part 11, 21 CFR part 820, EU Annex 11 and GAMP.
Key Words: Computer Systems Validation / CSV / Data Integrity / GAMP / GMP / Medical Devices / Pharmaceuticals / IT Validation / IT QA / Quality Assurance / Equipment Software Validation / Software Validation / 21 CFR Part 11 / 21 CFR part 820 / EU Annex 11 / GAMP5 / CSV Manager / Data Integrity Manager / Data / Compliance / Risk Management
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.
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