Overview

Reference Number: JO-2110-479226
Quality Control Supervisor
Rate: Negotiable
Job Type: Permanent
Location: Athlone

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.

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