CSV Specialist DAY RATE CONTRACT 10 MONTHS

CSV Specialist DAY RATE CONTRACT 10 MONTHS

Main duties/responsibilities:

• Participate in activities/projects as CSV subject matter expert
• Plan, write, implement, and review the computer systems validation (CSV) protocols in place
• Documentation - write, maintain, review, and update validation documentation, and approve validation SOPs.
• Review validation data, compile reports and support internal & external audits if required.
• To implement cGMP, MHRA and FDA requirements across IT systems and to ensure compliance to these and current best practices.
• Review potential suppliers for their suitability to supply computer software and equipment to GMP/GAMP standards.
• Assess the impact of any changes to manufacturing systems with the relevant SME/Vendor
• Provide CSV advice and recommendations to IT department and other stakeholders as required
• Training staff on the computerised systems in line with the relevant protocols and regulations.
• Stay informed with latest technological developments within the manufacturing industry.
• Propose and implement validation process and efficiency improvements.

Tools and equipment used:

• Standard Microsoft Office Applications
• Microsoft Project/Visio
• Outlook
• eValidation tool if available

Working conditions:

• The position will be based in Hatfield (hybrid working)

Working relationships:

• Reports to Business Process Expert - Technical Lead to MES project
• Work in partnership with Management, Stakeholders and Users to proactively maintain, develop existing and new IT services/business systems
• Work in collaboration with Manufacturing, Quality and Engineering groups
• Works closely with other EIT teams
• Works closely with External system providers and vendors