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.

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