Senior QC Reviewer: Data Integrity & GMP Expert

L M Manufacturing Limited; Northampton; In loco; GBP 42.000 - 68.000; Tempo pieno

Descrizione del lavoro

L M Manufacturing Limited seeks an experienced Senior Quality Control Reviewer to join our pharmaceutical Quality Control team. You will review analytical data and laboratory records to ensure accuracy, completeness and compliance with approved procedures, GMP requirements and data integrity principles.

Key responsibilities include reviewing data from HPLC, GC, UV, IR and dissolution testing, verifying calculations, audit trails in Caliber LIMS and Chromeleon, and coordinating with QA, Warehouse

Competenze

• Degree in Chemistry, Pharmaceutical Sciences or a related scientific discipline.
• Typically 8–12 years of relevant experience in pharmaceutical Quality Control, with substantial experience reviewing analytical data.
• Strong working knowledge of HPLC, GC, UV, IR, dissolution testing and associated laboratory documentation.
• Sound understanding of GMP, GLP, ALCOA+ principles and laboratory investigation processes.
• Experience reviewing electronic records and audit trails; familiarity with Caliber LIMS and Chromeleon is desirable.

Mansioni

• Review raw analytical data for materials, in-process samples, finished products and stability studies against specifications and test procedures.
• Review data generated using HPLC, GC, UV, IR, dissolution apparatus and other analytical instruments.
• Verify calculations, results and supporting documentation, ensuring records are accurate, complete, legible and traceable.
• Check compliance with GMP, GLP, applicable procedures and ALCOA+ data integrity principles.
• Identify discrepancies, deviations, OOS, OOT and atypical results and escalate appropriately.
• Review laboratory notebooks, worksheets, electronic records and certificates of analysis for audit readiness.
• Support investigations into OOS, OOT and atypical results by reviewing analytical data.
• Review instrument calibration and associated documentation to confirm compliance with requirements.
• Review electronic audit trails within Caliber LIMS, Chromeleon and other laboratory software.
• Collaborate with analysts, QA, Warehouse and Production to resolve queries and support timely data reviews.
• Provide clear feedback to analysts and ensure corrections are documented per procedures.

Conoscenze

Attention to detail

Analytical judgement

Communication skills

Prioritisation

Formazione

Degree in Chemistry or Pharmaceutical Sciences

Strumenti

Caliber LIMS

Chromeleon

Descrizione del lavoro

L M Manufacturing Limited seeks an experienced Senior Quality Control Reviewer to join our pharmaceutical Quality Control team. You will review analytical data and laboratory records to ensure accuracy, completeness and compliance with approved procedures, GMP requirements and data integrity principles.

Key responsibilities include reviewing data from HPLC, GC, UV, IR and dissolution testing, verifying calculations, audit trails in Caliber LIMS and Chromeleon, and coordinating with QA, Warehouse