Senior Quality Control Reviewer

Job description

About the role

We are seeking 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, specifications, GMP requirements and data integrity principles.

Key responsibilities

• Review raw analytical data for raw materials, packaging materials, in-process samples, finished products and stability studies against approved specifications and standard 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 Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable procedures and ALCOA+ data integrity principles.
• Identify and escalate discrepancies, deviations, out-of-specification (OOS), out-of-trend (OOT) and atypical results.
• Review laboratory notebooks, worksheets, electronic records and certificates of analysis, ensuring documentation is ready for audits and inspections.
• Support investigations into OOS, OOT and atypical results by reviewing relevant analytical data and records.
• Review instrument calibration and associated documentation to confirm compliance with approved requirements.
• Review electronic audit trails within Caliber LIMS, Chromeleon and other relevant laboratory software.
• Work closely with laboratory analysts, Quality Assurance, Warehouse and Production teams to resolve queries and support timely completion of data reviews.
• Provide clear feedback to analysts and ensure corrections are appropriately documented in accordance with approved procedures.

Qualifications and experience

• A 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.
• Excellent attention to detail, sound analytical judgement and strong communication skills.
• Ability to manage competing priorities and work collaboratively across departments.

Reference 225811720