Our client a Pharmaceutical Manufacturer whose technologies and discoveries have contributed to the development of medicines that have helped shape the treatment landscape, and form the basis for our current investigational products in a range of disease areas, is currently looking to appoint a Quality Control Supervisor
Key Responsibilities of the Quality Control Lead Supervisor
• To supervise testing and release of In Process and Finished Products (including Stability samples) required to support both commercial and development projects.
To lead and manage:
• 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 e.g. monthly quality report, analysis trending reports, exceptions reports, KPI reports, etc.
• Communicate to senior management on key events and issues etc. via normal in-house reporting structure e.g. meetings, formal reports, etc.
Requirements:
• 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 e.g. 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 (e.g. UV, IR, Raman).
• Previous experience of FDA/HPRA regulated site including regulatory audit preparation and auditor interaction experience e.g. 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 e.g. 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.