Senior Quality Control Executive

Role & responsibilities

Key Responsibilities

Stability Programme Management

• Create, review and update Stability Study Protocols in line with ICH Q1 guidelines, marketing authorisation commitments and regulatory requirements.
• Track stability timepoints, sample pulls, testing schedules and reporting timelines across multiple products and stability chambers.
• Conduct proactive follow-ups with UK QC Chemistry and Microbiology teams to ensure timely completion of stability testing.
• Maintain and continuously update stability dashboards, trend charts, visual trackers and progress reports.
• Analyse stability trends and summarise results, identifying early signs of product degradation, microbial shifts, preservative failure or parameter drift.
• Escalate adverse trends, potential specification deviations, and atypical results to UK QC leadership and support further investigation.

QC Laboratory Support

• Liaise with UK laboratories to facilitate smooth communication on analytical and microbiological testing priorities.
• Support data collation and trending for key parameters such as assay, pH, viscosity, specific gravity, appearance, microbial limits and preservative efficacy.
• Perform statistical analysis of data trends to see if the process is under state of control
• Assist in documentation of open tests, repeats, retests, re-sampling and pending investigations to ensure transparency and traceability.
• Prepare regular QC performance summaries, turnaround status updates and sample management records.
• Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.

QC-Linked QA Documentation & Compliance

• Draft and support documentation for Incidents, Deviations, OOS, OOT and laboratory investigations, ensuring clarity and regulatory alignment.
• Assist with evidence collection, data review and root cause analysis, supporting UK QC with timely CAPA follow-up.
• Ensure QC documentation meets Good Documentation Practice (GDP) standards and supports audit readiness for MHRA and customer inspections.

Support to Product Development through to Commercial

• Assist stability and data monitoring activities for new product development batches, scale-up batches and validation studies.
• Prepare comparative trending summaries to support formulation optimisation and lifecycle management.
• Review critically all the documentations generated in analytical method validation and technical transfer as per the requirements of ICH Q2 and Chapter 6 of EUGMP

Preferred candidate profile

• Degree in Pharmaceutical Sciences, Chemistry, Microbiology or related discipline.
• 6+ years experience in Quality Control within a GMP pharmaceutical environment.
• Experience working with oral liquid solutions or suspensions is desirable.
• Strong Excel, dashboarding and data visualization skills.
• Understanding of ICH Q1 stability requirements, laboratory workflows and EU GMP expectations.
• Strong communication and coordination skills across sites and time zones.