• You will be responsible for managing testing and release of In Process and Finished Products (including Stability samples) required to support both commercial and development projects.

• You will lead and manage QC Laboratory Supervisors with responsibility for Quality Control laboratory teams while ensuring high cGMP and GLP standards are maintained, and adherence to schedules and targets to meet regulatory and business requirements.

• You will be responsible for the employee relations, change, policy implementation, motivation, discipline, target setting, communications, occupational health & safety, training.

• You will manage laboratory investigations using systematic RCA approach and effective CAPA planning. Ensure follow-up on anomalies, failures, and external complaints.

• You will prepare, review and approve documents such as SOP's, Analytical Protocols, Reports and documentation for audits carried out by internal auditors and regulatory authorities.

• You will actively lead and support major site projects, quality initiatives and continuous improvement programmes within the QC department.

• You will be responsible for preparing and reviewing QC department reports and metrics e.g. monthly quality report, analysis trending reports, exceptions reports, KPI reports, etc.

• You will be in charge of the control of QC annual budget for consumables, capital and headcount.

• You are Degree qualified in Science or related discipline.

• You have 10 years of experience in a pharmaceutical environment.

• You have 3 years of QC Laboratory Management experience.

• You have previous experience in leading and influencing positive change initiatives e.g. department improvement initiatives, six sigma lean lab, systematic root cause analysis (RCA) and effective CAPA implementation for laboratory investigations.

• You have 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).

• You have previous experience of HPRA/FDA regulated site including regulatory audit preparation and auditor interaction experience e.g. HPRA, FDA.

• A competitive salary and benefits package.
• Plenty of opportunities for career progression.

The Next Step for you:

Interested in this role? Please send your CV to SIMONA MORELLI at Next Generation Recruitment by clicking on the Apply button!

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