QC Manager (Chemistry)
QC Manager - Permanent.
On behalf of our clients we are sourcing for a QC Manager (Chemistry). Reporting to the Associate Director of QC Laboratory Services the successful candidate will manage the Quality Control Testing Teams.
To manage testing and release of In Process and Finished Products (including Stability samples) required to support both commercial and development projects.
To 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.
- To ensure a high standard of housekeeping and safety is maintained within the QC Laboratory.
- Continuous management and appraisal of the performance and development of the Quality Control Testing Teams in accordance with the site performance for the growth development program.
- Employee relations, change, policy implementation, motivation, discipline, target setting, communications, occupational health & safety, training.
- Manage laboratory investigations using a systematic RCA approach and effective CAPA planning. Ensure follow-up on anomalies, failures, and external complaints.
- Prepare, review and approve documents such as SOP’s, Analytical Protocols, Reports, and documentation for audits carried out by internal auditors and regulatory authorities.
- Ensure QC laboratory readiness for internal, customer and regulatory inspections. Represent the Company at audits, client visits when required to do so. Follow up on the close out of actions/ recommendations identified from both internal and external audits.
- Actively lead and support major site projects, quality initiatives and continuous improvement programs within the QC department. Utilize available resources in an efficient manner to support business needs e.g. lean lab management methods, leading continuous development of lab technique training and associated improvement programs in the QC lab team.
- Collaborate with and influence internal and external stakeholders outside of QC department to ensure effective operation, compliance and deliverables are achieved.
- Prepare and review QC department reports and metrics e.g. monthly quality report, analysis trending reports, exceptions reports, KPI reports, etc.
- Control of QC annual budget for consumables, capital and headcount.
- Communicate to senior management on key events and issues etc. via normal in-house reporting structure e.g. meetings, formal reports, etc.
- Third level qualification (BSc or higher) in Science Related Discipline with desired 10 years’ experience in a pharmaceutical environment and a minimum of 3 years QC Laboratory Management experience.
- Laboratory Safety knowledge of best industry practices and experience in laboratory safety management.
- Previous management 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 effective 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 HPRA/FDA 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.
The ideal candidate will have proven people management experience, ability to lead/manage a team of analysts and supervisors in a busy lab production - that is expanding it's product output and bringing development products to commercialisation output. You will have experience in change projects including lean mgt tools such as six sigma practises and leading new lab improvement projects & initiatives, maximising existing lean mgt tools for best practise and operational excellence within a busy laboratory environment. This is a new role within a growing organisation bringing new products to the market, it will be busy, challenging and offer a great career opportunity for the right person and offers a competitive remuneration package.
For more information and a confidential discussion please contact Mary Mullin.
01 6620088 / 085 8718281