CSV Contractor

Location
Surrey
Salary
£50 to £60 per hour
Posted
31 May 2019
Closes
28 Jun 2019
Ref
J5631609
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
This is an opportunity for a Computer Systems Validation Contractor (CSV) to join a Pharmaceutical company based in the Surrey area.

As the CSV Contractor you will be responsible for the generation and execution of computer system validation protocols for the laboratory systems (LIMS) and compliance to cGMP standards.

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 be responsible for the Validation of the Laboratory Systems, e.g. HPLC. Here you will write Test Scripts, Protocols and execute Protocols / Reports.

2. You will be delivering Computer Systems Validation Projects; Network, Software, through to Laboratory Systems, Quality Systems and Control Systems (SCADA).

3. You will process and manage quality records including change control, deviations and Corrective and Preventative Actions (CAPAs).

4. You will consistently utilise knowledge and experience of Data Integrity, GAMP5, Laboratory Systems, Control Systems and Software Systems to deliver CSV projects throughout the business.

ROLE REQUIREMENTS:

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 the pharmaceutical / medical devices industry.

2. Proven industry experience with Laboratory Systems, Hardware Systems and Software Systems to GMP / GAMP5 regulations.

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 |

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