Quality Control Supervisor
My client a leading Multinational Pharmaceutical company now require a Quality Control Supervisor to join their expanding team.
This is a newly built facility and the Quality Control Supervisor will be responsible for the overall management of the Quality Control laboratory supporting the manufacture of a new biologics product.
This is a permanent role based in Dublin.
Responsibilities of Quality Control Supervisor
- Establish and lead the QC team supporting the technical transfer of product through to operation readiness: Method Transfer/Validation, incoming components and raw materials testing and release , product testing, in-processing testing and process validation
- Responsible for the QC Laboratory Start-up activities which includes development of URSs, Risk Assessments, Protocols, Reports, SOPs, EOPs work instructions, procurement and qualification of equipment, software and utilities/facilities.
- People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production mode.
- Responsible for the operation and inspection readiness of the QC laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Manage the incoming component/ raw material inspection and release testing to support the manufacturing of the product.
- Manage contract testing laboratories associated with QC testing
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
- Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
- Generate, implement and control of QC lab annual budget for consumables, capital and headcount.
- As required, act as designee for the QC Bioprocessing Laboratory Manager in their absence.
Requirements of Quality Control Supervisor
- 5 years’ experience working in Quality Control in the pharmaceutical industry, preferably in a Biopharmaceutical company
- Extensive experience of chemistry testing
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Previous experience managing the performance of individual team members and the overall team
- Knowledge and experience of Lean Laboratories is preferable
- Previous experience in setting up a new QC laboratory is desirable
- Experience working in a Biologics facility, desirable but not essential