Computer Systems Specialist
Major Duties and Responsibilities
• To implement cGMP, MHRA and FDA requirements across IT GxP 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 write IT system Project documentation, including; Tender documentation, supplier responses and supplier audit details
• To write and execute system validation documentation including; Risk Assessments, FDS VAP, URS, UAT, IQ/OQ and PQ.
• Provide CSV advice and recommendations to stakeholders as required
• 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 Owner / Administrator for assigned computer systems
• Management of the validation life cycle of IT manufacturing business systems including:
• Environmental monitoring systems
• Serialisation and decommissioning systems relating to the Falsified Medicines Directive
• Systems supporting manufacturing and packaging operations.
Knowledge and Experience
• Degree or equivalent qualified (no specific subject required)
• Understanding of Computer Systems Validation (CSV)
• Understanding of GAMP 5
• Experience of ICT and business system lifecycle management preferably in a pharmaceutical manufacturing or other regulated environment
• Experience as acting as a System Administrator
• 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