Job Description
The QC Laboratory Supervisor is responsible for leading a team and applying technical expertise to support analytical testing of finished products and raw materials. This involves ensuring compliance with cGMP, Health and Safety, SOPs, environmental, and regulatory requirements while meeting customer needs.
This role reports to the QC Laboratory Manager and requires a bachelor's degree in a science-based discipline along with at least 5 years of relevant experience in a pharmaceutical environment. Key responsibilities include:
* Leading a team of Quality Analysts and ensuring all testing is conducted in accordance with current EU and Pharmacopeial requirements.
* Planning, scheduling, and coordinating analytical testing within the team.
* Ensuring the highest standards with regard to data integrity and compliance with current guidelines.
* Managing analyst performance, including annual reviews, ongoing development plans, time and attendance, and training records.
* Achieving required testing schedules by assigning and ensuring team and individual KPIs are met, allowing the timely completion of testing to meet planned due dates.
* Ensuring the timely review and approval of laboratory results, protocols, and reports for finished products and stability studies.
* Providing technical guidance in the event of equipment failure, calibration failure, out-of-specification (OOS) results, and any other laboratory issues as appropriate.
* Ensuring all laboratory equipment is maintained and calibrated.
* Performing detailed root cause investigations into out-of-specification (OOS) results or any analytical errors that occur in the laboratory.
* Ensuring method transfer activities are completed on time within the team.
* Ensuring adherence to all relevant Standard Operating Procedures (SOPs), Calibration and Operation Instructions (COIs), and existing test methods, with reference to pharmacopoeias, specifications, regulations, and industry standards.
* Conducting statistical trend analysis in accordance with current GMP/GLP requirements.
* Supporting reviewers in reviewing all laboratory notebooks, records, chromatograms, etc., to ensure compliance with GLP standards.
* Managing consumables stock levels in the laboratory.
* Ensuring that relevant working standards and reference standards are always available and not expired.
* Assisting the QC Manager in hosting regulatory inspections and customer audits.
* Ensuring that corrective actions identified from observations raised during regulatory and customer audits are implemented in a timely manner.
* Ensuring that all GMP-related documentation is regularly reviewed and updated in accordance with company policy.
* Supporting the QC Manager in reviewing and approving company Standard Operating Procedures (SOPs).
* Ensuring that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.