Senior QC Analyst: Data Integrity & Audit Champion

Piramal Pharma Limited; Bethlehem; On-site; GBP 42,000 - 64,000; Full time

Job summary

Piramal Pharma Limited’s Piramal Critical Care unit seeks a Senior Quality Control Analyst to perform analytical testing across in-process materials, bulk drug substance, finished products, and stability samples. The role supports QC compliance, audits, data integrity, and training within a cGMP/GDP environment.

The candidate will calibrate instruments (GC, HPLC, UV/Vis, IR), review data, and contribute to investigations and CAPAs while ensuring timely, accurate documentation.

Qualifications

• Experience with cGMP and regulatory audits is essential.
• Strong data integrity mindset and familiarity with electronic lab records.
• Proficient in chromatographic techniques (GC, HPLC) and analytical testing.

Responsibilities

• Perform analytical testing of in-process material, bulk drug substance, finished drug product, and stability samples.
• Monitor QC compliance with electronic systems and laboratory applications.
• Support audits/inspections and respond to observations.
• Serve as QC Data Integrity and Compliance (DICO) Champion.
• Maintain documentation according to cGMP and GDP.
• Calibrate and troubleshoot laboratory instruments (GC, HPLC, UV/Vis, IR, etc.).
• Assist in investigations, CAPA, and deviations related to QC labs.
• Train new hires and oversee QC training structures.
• Prepare quality metrics for turnaround times and data trends.
• Review raw data and support stability put-ups/take-outs as needed.

Skills

QC Data Integrity

GC/HPLC

Analytical Testing

cGMP compliance

21 CFR Part 11

Audit Readiness

Documentation

Training & Mentoring

Laboratory Instrumentation

Sampling & QC Inspection

Tools

Instrument Calibration

Laboratory IT systems

Job description

Piramal Pharma Limited’s Piramal Critical Care unit seeks a Senior Quality Control Analyst to perform analytical testing across in-process materials, bulk drug substance, finished products, and stability samples. The role supports QC compliance, audits, data integrity, and training within a cGMP/GDP environment.

The candidate will calibrate instruments (GC, HPLC, UV/Vis, IR), review data, and contribute to investigations and CAPAs while ensuring timely, accurate documentation.