QC Validation & Systems Lead

QC Validation & Systems Lead

Cheshire
£40,000 – £50,000
Pharmaceutical / GMP Laboratory

The Role

We are seeking an experienced QC Validation & Systems Lead to take ownership of QC laboratory equipment lifecycles and computerized systems within a GMP-regulated environment.

This senior, hands-on role blends equipment validation, CSV, data integrity, and team leadership, ensuring QC operations remain compliant, efficient and inspection-ready at all times.

Key Responsibilities

• Own the full lifecycle of QC laboratory equipment, including procurement, qualification, maintenance, change control, and retirement
• Lead equipment validation activities (IQ/OQ/PQ) and manage site calibration programmes, including oversight of external service providers
• Manage QC equipment and validation status using electronic systems (e.g. LIMS), ensuring GMP compliance and inspection readiness
• Lead Computer System Validation (CSV) and administration for QC systems such as Empower and LabX, ensuring data integrity and regulatory compliance
• Author and approve validation and GMP documentation, and lead deviation investigations, impact assessments, and CAPA related to equipment and systems
• Provide technical leadership and line management to a small QC systems team and act as SME during internal and regulatory audits

The QC Validation Lead must have:

• Degree (BSc or equivalent) in Chemistry or a relevant scientific discipline, with essential HPLC experience in a pharmaceutical or GMP-regulated laboratory
• Strong working knowledge of GMP, Health & Safety and COSHH requirements
• Proven experience in laboratory equipment qualification, validation, calibration, and troubleshooting especially for HPLC systems
• Hands-on experience with QC computerized systems (e.g. Empower, LabX), including CSV and a solid understanding of Data Integrity principles
• Confidence representing QC during audits and inspections, with previous supervisory or team leadership experience preferred

Please note: my client is unable to offer sponsorship on this role.