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Information Systems Analyst - CSV Pharmaceutical
Description
This growing pharmaceutical company are looking for someone with experience of computer systems validation (CSV) in an automated manufacturing and production pharmaceutical business. You will need to have knowledge and experience of computer system implementation & validation within a pharmaceutical environment working to GAMP, 21 CFR Part 11, Annex 11 and Data Integrity guidance. Experience of writing and executing validation test documents (IQ, OQ, PQ) and Experience of compliance maintenance through documented change management. A good background in pharmaceutical/life science industry experience.

You will be interfacing and collaborating with both technical and non-technical colleagues including IT contractors/developers, business stakeholders and customers, vendors/suppliers, at all levels including senior management and board level.

The Manufacturing Senior Information Services (IS) Analyst is a business partner to the Production groups. Focussing on gaining an in depth understanding of business partner processes, creating strong collaborative relationships and playing a critical role in the selection, design, implementation, validation and adoption of new information systems. As Senior Analyst you will mentor other Analysts in the understanding of business partner processes, system design and implementation.

1. KEY RESPONSIBILITIES/ACCOUNTABILITIES

- Deliver high-value systems aligned with business requirements, collaborating closely during system selection, design, implementation, validation and roll-out.
- Supporting effective adoption of new systems by working closely with business partners to put in place high-quality training materials and user support.
- Gain a detailed knowledge of stakeholder business processes through shadowing, process review, and collaboration.
- Develop close working relationships with stakeholder teams through effective project engagement and consistent project delivery.
- Maintain knowledge of associated regulations and guidance, influencing approach to the application through collaboration with CSV Manager.
- Work closely with business partners to ensure systems meet regulatory requirements utilising a risk-based approach to system validation.
- Administrates business systems, to help maintain system data integrity.
- Mentors other analysts to support them in understanding business partner processes and requirements along with the design and delivery of those information systems.
Job Details
Job Ref: 219880568
Hours: Not Specified
Location: Rochester, Kent, United Kingdom
Working Term: Permanent
Salary: GBP GBP - Annual Dependent on experience Annual, Dependent on experience