Computer System Validation Specialist – Basildon – Hybrid – Pharmanovia Pharmanovia is a fast-growing global specialty pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Since our founding in 2013, we have focused on revitalising niche, trusted medicines to improve patient outcomes worldwide. We are committed to delivering quality, innovation, and responsible lifecycle management of established medicines across our core therapeutic areas: Cardiovascular, Oncology, Endocrinology, and Neurology.
We are looking for an experienced Computerised Systems Compliance Manager to help safeguard patient safety through GxP compliance and data integrity.
Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance Lead and support internal, client and regulatory audits relating to computerised systems Review and approve system implementation plans, upgrades and change control activities Identify compliance gaps and support remediation, CAPA planning, and execution Conduct and communicate risk assessments associated with computerised systems Establish and report KPIs related to computerised systems at Quality Review Meetings Demonstrated experience managing computerised systems validation in a pharmaceutical, biotech, or life sciences environment, with a strong focus on GxP compliance and validation processes.
Good Manufacturing Practice (GMP) and GxP~ Data integrity principles and MHRA expectations~ Experience supporting or leading regulatory inspections and audits
Ability to translate complex technical and regulatory concepts into clear, practical guidance Professional, reliable and committed to maintaining quality and compliance standards
Be part of a growing global pharmaceutical organisation with a strong pipeline and expanding footprint Play a key role in ensuring patient safety and regulatory compliance across a diverse portfolio of established medicines
Pharmanovia is committed to diversity and inclusivity….