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An exciting opportunity for a CSV Specialist to join a leading Biopharmaceutical company based in the Berkshire area has become available. As the CSV Specialist you will be responsible for the generation and execution of computer system validation protocols and reports in line with cGMP, Annexe 11 and 21CFR Part 11.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:
1. You will generate and execute validation project plans, protocols and reports. You will also plan and manage the delivery of validation projects and procedures to meet regulations and guidelines.
2. You will review validation protocols, reports and procedures generated by the company's staff or external vendors
3. You will process and manage quality records including change control, deviations and Corrective and Preventative Actions (CAPAs)
4. You will plan all work and report progress to the validation scheduler, line manager and internal customer to ensure validation activities are aligned.
To be successful in your application to this exciting opportunity as the CSV Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science or engineering discipline and experience delivering CSV projects within a biopharmaceutical industry.
2. Proven industry experience with hardware and software in a GMP environment
3. A working knowledge and practical experience with Pharmaceutical Quality Systems including change control, deviation, CAPAs
Key Words: CSV | Computer Systems | Validation | GMP | GAMP Annexe 11 | 21CFR Part 11 | Biopharmaceutical | Pharmaceutical | Change Control| Deviations | IQ | OQ | PQ | QMS | Quality Management Systems | CAPAs |
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.