Job Summary

Computer Systems Validation Engineer

Wiltshire | | Pharmaceutical Industry

Recruiter: Hyper Recruitment Solutions

Job InformationRole Overview We are currently looking for a Computer Systems Validation Engineer to join a leading pharmaceutical company based in the Wiltshire area. As the Computer Systems Validation Engineer you will be responsible for supporting?Computer Systems Validation (CSV)?activities regarding new and existing GxP systems supporting the site regulated business process Key Duties and Responsibilities Your duties as the Computer Systems Validation (CSV) Engineer your role will be varied however the key duties and responsibilities are as follows:1. Your main focus as the CSV Engineer will be to support?Computer Systems Validation (CSV)?activities regarding new and existing GxP systems supporting the site regulated business process2. You will provide specialized knowledge and information to guarantee the proper computerised system Life cycle from installation, to retirement ensuring the compliance with relevant regulatory requirements including FDA 21 CFR Parts 11 and 211 and EU GMP Annexes 11 and 15 and MHRA Guidance with a focus on the ER/ES compliance and DI principles.3. You will be responsible for validation activities following a risk-based approach in accordance to GAMP 5 guide and the CS life cycle methodology are incorporated and documented appropriately for the systems in accordance with company standards and site procedures4. You will work closely with all functions and in particular with project leaders, Engineering, IT, DI, QC and Quality Role Requirements To be successful in your application to this exciting opportunity as the Computer Systems Validation Engineer we are looking to identify the following on your profile and past history:1. Good Knowledge of GAMP5 guide and MHRA ‘GXP Data Integrity Guidance and Definitions, FDA 21 CFR Part 11, EMEA Annex 11 regulations 2. Proven industry experience in Computer systems within the pharmaceutical industry 3. Experience with automation, computer and manufacturing systems especially in the sterile environment Key Words: CSV, Computer System Validation, GXP, Data Integrity, GAMP5, Validation More

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