The Quality Control Supervisor will supervise all aspects of the Quality Control In-Process and Finished Product Testing Team.
Reporting to the Manager of QC Laboratory Services
- To supervise testing and release of In-Process and Finished Products (including Stability samples) required to support both commercial and development projects.
- A group of analysts while ensuring high cGMP and GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
- Continuous management and appraisal of the performance and development of a group of analysts in accordance with the site performance for growth development program.
- Employee relations, change, policy implementation, motivation, discipline, target setting, communications, occupational health & safety, training.
- Perform investigations using systematic RCA approach and effective CAPA planning. Ensure follow-up on anomalies, failures, and external complaints.
- Regulatory compliance through the creation and maintenance of controlled documentation for training, SOPs, and analytical protocols.
- Preparation of documentation for audits carried out by internal auditors and Regulatory bodies. Follow up on the close-out of actions/ recommendations identified from both internal and external audits.
- Utilising available resources in an efficient manner - lean lab management methods, leading continuous development of lab technique training and associated improvement programs in a QC lab team.
- Prepare and review QC department reports and metrics monthly quality reports, analysis trending reports, exceptions reports, KPI reports.
- Communicate to senior management on key events and issues etc. via normal in-house reporting structure meetings, formal reports.
- ?Third level qualification (BSc or higher) in Science Related Discipline with desired 6 years’ experience in a pharmaceutical environment.
- Laboratory Safety knowledge of best industry practices and experience in laboratory safety management.
- Previous supervisory experience is necessary along with the ability to influence peer group.
- Previous experience in leading and influencing positive change initiatives department improvement initiatives, six sigma lean lab, systematic root cause analysis (RCA) and CAPA implementation for laboratory investigations.
- Technical troubleshooting experience understands data-driven decision making, critical thinking and experienced in problem-solving skills in HPLC-related methodologies, Dissolution, Moisture, and Spectroscopy methodologies (UV, IR, Raman).
- Previous experience of FDA/HPRA regulated site including regulatory audit preparation and auditor interaction experience HPRA, FDA.
- Excellent knowledge of laboratory testing practices, transfer and validation of analytical methods and cGMP applicable to a pharmaceutical environment.
- Proven planning and organisational skills previous project lead experience.
- Excellent written and oral communication skills.
- Proven track record in your current role is essential.
- Responds positively to changing circumstances and priorities.