Computer Systems Validation (CSV), Analyst
Based: Hatfield, Herts
Permanent full time position
Competitive salary and excellent corporate benefits including 24 days holiday, and up to 12.5% Bonus

Our client is a world leading research-based pharmaceutical company renowned for pushing the boundaries of medical innovation are seeking an experienced CSV Analyst, Manufacturing Business Systems for the ICT Business Solutions Department to increase Manufacturing's business effectiveness and future IT capabilities through Innovation, Automation and Electronic systems.

This role will contribute towards:

* The development and execution of qualification packages, validation plans, test scripts and Protocols
* Ensuring the implementation and life cycle management of IT systems meet manufacturing regulatory guidelines such as Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practices (GAMP)

Main duties/responsibilities:

* To implement cGMP, MHRA and FDA requirements across IT systems and to ensure compliance to these and current best practices.
* To write or support Policies and Procedures regarding computerised systems and ensure adherence to these and other related Policies.
* Review potential suppliers for their suitability to supply computer software and equipment to GMP/GAMP standards.
* To review IT system Project documentation, including URS, Tender documentation, supplier responses and supplier audit details
* Provide CSV advice and recommendations to IT department and other stakeholders as required
* Build and maintain relationships with Business systems vendors
* Assist Manager in conducting periodic service reviews of key business systems
* Participate in activities/projects as CSV subject matter expert
* Stay informed with latest technological developments within the manufacturing industry
* Act as the System Administrator for assigned computer systems
* On occasion participate in other activities/projects
* Management of the validation life cycle of IT manufacturing business systems including:
 Dispensary Management System (DMS)
 Environmental Monitoring System (EMS)
 Maximo Assets Management System (CMMS)
 TrackWise Quality Management System (QMS)

Experience required:
* Degree or equivalent qualified (no specific subject required)
* Understanding of Computer Systems Validation (CSV)
* Understanding of GAMP
* Experience of ICT and business system lifecycle management preferably in a pharmaceutical manufacturing or other regulated environment
* Documentation and testing experience of ICT systems
* Understanding of GMP and its implications on ICT
* Broad range of knowledge in systems/applications relevant to pharmaceutical manufacturing
* A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT hardware, software architecture and IT infrastructure concepts

Our clients' employees are creative, highly motivated and share a passion for patient care. With huge scope for personal growth and development within the company - there is a bright future waiting for you. If you are interested and feel that you have the right skills then please apply directly to this role.

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

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