Senior Validation Analyst - GMP QC (12-Month)

Randstad CPE; West Kirby; In loco; GBP 42.000 - 60.000; Tempo pieno

Descrizione del lavoro

Randstad CPE seeks an experienced Validation Analyst for a 12-month on-site contract in Liverpool. You will own method validation packages, conduct historical data reviews and robustness studies within a GMP environment.

Responsibilities include end-to-end analytical method validation (ICH Q2(R2), USP, Ph.), gap remediation, instrument/system validation reviews, and regulatory-compliant reporting. Suitable candidates have HPLC and wet chemistry expertise, data analysis skills, and LIMS

Competenze

• Proven Industry Experience: Prior industrial laboratory experience in a regulated GMP environment (Pharmaceutical, Biopharma, Fine Chemicals, or Medical Devices/Healthcare).
• Analytical Validation Expertise: Demonstrated track record with analytical method validation, verification, and transfer protocols against ICH/pharmacopoeial standards.
• Laboratory Competencies: Strong working background in HPLC analysis and troubleshooting.
• Hands-on proficiency with wet chemistry techniques and standard laboratory instrumentation (e.g., UV-Vis, pH, conductivity, titrations).
• Data Management: Strong numerical analysis and data interpretation skills; intermediate-to-advanced proficiency in Microsoft Excel and the broader MS Office suite.
• Systems: Adaptable to learning proprietary in-house Laboratory Information Management Systems (LIMS) and quality management platforms.

Mansioni

• Analytical Method Validation: Execute end-to‑end QC chemistry (and microbial, where applicable) method validation in compliance with ICH Q2(R2) , USP , and Ph.
• Eur. guidelines across both instrumentation and traditional wet chemistry techniques.
• Gap Remediation & Robustness: Address and close out identified technical gaps, including assessing method robustness and completing analytical remediation protocols.
• Historical Data Review: Conduct thorough historical QC method performance reviews and data validation assessments to bring analytical packages up to modern compliance standards (addressing multi-year data validation backlogs). System & Instrument Review: Support QC analytical instrument and data system validation reviews, ensuring data integrity and audit readiness.
• Technical Reporting: Compile, analyze, and present complex analytical validation data into clear, regulatory‑compliant reports and validation summaries.

Conoscenze

Analytical method validation

Laboratory analysis

HPLC analysis

Wet chemistry techniques

Data interpretation

Instrument troubleshooting

Compliance awareness

Strumenti

Microsoft Excel

Laboratory Information Management System (LIMS)

MS Office Suite

Descrizione del lavoro

Randstad CPE seeks an experienced Validation Analyst for a 12-month on-site contract in Liverpool. You will own method validation packages, conduct historical data reviews and robustness studies within a GMP environment.

Responsibilities include end-to-end analytical method validation (ICH Q2(R2), USP, Ph.), gap remediation, instrument/system validation reviews, and regulatory-compliant reporting. Suitable candidates have HPLC and wet chemistry expertise, data analysis skills, and LIMS