Quality Control Laboratory Manager detailed Job Description
Cpl are delighted to work with our Pharmaceutical client partner who are based in the Midlands and due to the launch of a new product on-site which is now in full commercial production, they are seeking to recruit and experienced QC Laboratory Manager to join the team
The company are a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio including the manufacturing or their own range or proprietary drug products all manufactured and packaged on-site as well as a portfolio of contract manufacturing for a wide customer base.
We are now accepting Applications from interested and highly experienced QC Laboratory Managerial professionals who are interested in a role with a highly progressive Pharma company in the midlands.
Reporting to the Associate Director of QC Laboratory Services the successful QC Laboratory Manager will manage the Quality Control Testing Teams (comprising a team of 2 QC Supervisors each leading a team of 10 QC Testing Analysts who are working a rotating 2 cycle shift Monday to Friday)
You will 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:
· 2 x QC Laboratory Supervisors with responsibility for 20 x Quality Control laboratory teams (10 per team across 2 shifts ) while ensuring high cGMP and GLP standards are maintained, and adherence to schedules and targets to meet regulatory and business requirements.
· The QC Manager will ensure a high standard of housekeeping and safety is maintained within the QC Laboratory.
· You will have responsibility for ensuring Continuous management and appraisal of the performance and development of the Quality Control Testing Teams in accordance with the site performance for growth development program.
· Employee relations, change, policy implementation, motivation, discipline, target setting, communications, occupational health & safety, training are crucial in this roles as the company are in the process of recruiting a new of new QC Lab Testing Analysts and their training and development will be key over the coming 12 months.
· Manage laboratory investigations using 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 programmes within the QC department. Utilise 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.
If you are interested in this exciting new opportunity then please send your CV to me [email protected] in total confidence and I will reply to your application with initial feedback withing 24 – 36 hours of receipt of your CV