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Quality Control Supervisor

Contract Type: Permanent
Location: Unknown
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie

Job Description

Quality Control Supervisor -Perm
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
Key Responsibilities
  • 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 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.
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 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.