QC Laboratory Supervisor

Chanelle Pharma

Loughrea, Ireland

The role involves managing a team and applying technical expertise to support analytical testing of finished products and raw materials. This must be done using the correct procedures to comply with cGMP, Health and Safety, SOPs, environmental, and regulatory requirements while ensuring customer needs are met. This position reports to the QC Laboratory Manager.

As a QC Laboratory Supervisor, you will be responsible for:

Managing a team of Quality Analysts and ensuring that 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.
Performing any other duties assigned by the QC Manager.

Education & Experience:

Bachelor’s degree in a science-based discipline.
Minimum of 5 years of relevant experience in a pharmaceutical environment.
People management experience with the ability to lead and motivate a team.
Experience working within a pharmaceutical cGMP environment, with knowledge of EU GMP.

Skills & Competencies:

Strong computer skills, particularly in Microsoft Office.
Strong organizational skills, time management skills, and the ability to prioritize competing demands.
People management experience with the ability to lead and motivate a team.
Strong technical skills and working knowledge of the most common analytical techniques and relevant software.
Strong adherence to ALCOA+ data integrity principles.
Ability to build relationships and collaborate effectively with others.
Excellent communication skills, both verbal and written.
Strong analytical ability and problem-solving skills.
Flexible and willing to learn and develop new technical & people skills.