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Position Description

Supervisor, Quality Control
Job ID 11197
Location Athlone, IRE
Field Locations
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Job Description

Applicants are invited for the permanent role of Supervisor, Quality Control. Reporting to the Manager of QC Laboratory Services the successful candidate will supervise all aspects of the Quality Control In-Process and Finished Product Testing Team.

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 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.

 Alkermes provides equal employment opportunities to all employees and applicants for employment

Experience Level:
Mid-Senior Level
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