Computer Systems Validation Specialist

The Computer Systems Validation Specialist position centres on providing overall compliance oversight for all GxP computerised systems across Pharmanovia. It would suit someone who can bring careful technical judgement and practical problem-solving to the role.

Known job details

• Work model: Hybrid
• Computer System Validation Specialist - Basildon - Hybrid - Pharmanovia.

Likely focus of the role

• Provide overall compliance oversight for all GxP computerised systems across Pharmanovia.
• Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance.
• Maintaining computerised systems validation and lifecycle management processes.

Requirements mentioned

• Must have 3-5 years of experience working with Trackwise Digital.
• Experience with leading EQMS & ERP systems with a strong background in system administration and user experience.
• Previous QA experience in the management of (CAPA, Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls.