SciPro are supporting a Pharmaceutical manufacturing client in their search for a Senior Validation Engineer to join their Quality Control team. The role will focus on analytical method validation, transfers, implementation and lifecycle management, working closely with QC, QA, production teams and external laboratory partners.

Key Responsibilities

• Lead analytical method transfers, validations, verifications and implementation within the QC Chemistry Laboratory
• Author, review and approve analytical methods and associated technical documentation
• Review specifications for raw materials and packaging materials against GMP and Pharmaceutical requirements
• Manage collaboration with external laboratories, including transfer protocols, reports and associated agreements
• Prepare and approve SOPs, validation protocols and reports, risk assessments and specifications
• Coordinate the implementation of Pharmaceutical updates and verification of compendial methods
• Provide technical and scientific expertise across analytical validation activities
• Manage change controls, deviations and CAPA activities in accordance with the Quality Management System
• Support audits and represent QC Validation in discussions with customers and regulatory authorities

Key Qualifications & Experience

• Master's degree or equivalent in Chemistry, Pharmacy, Biotechnology, Microbiology or a related scientific discipline
• Previous experience within Quality Control in the pharmaceutical industry
• Strong experience in analytical method validation and/or transfer
• Experience working with a range of analytical techniques
• Knowledge of USP and Ph. Eur. requirements is advantageous
• Familiarity with relevant regulatory guidance, including ICH Q2(R2), ICH Q14 and EU GMP Annex 1
• Strong understanding of GMP requirements and pharmaceutical quality systems
• Experience working cross-functionally with QC, QA, production and external laboratory partners