My client a leading and rapidly expanding Pharmaceutical Company now require a Quality Control Manager to join their rapidly expanding team.
The Quality Control Manager is responsible for both the QC Testing and Microbiological Testing activities for the Biologics manufacturing facility.
This is a permanent role based in Dublin.
Responsibilities for Quality Control Manager:
- Responsible for the overall management of separate Quality Control laboratories supporting the manufacture of Cell Therapy. The QC laboratories operate on 24/7 and other shift rotas as required.
- Ensure that QC laboratories are set up and operate 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.
- Develop and maintain excellent communication and collaboration between QC and other work areas.
- Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC and microbiological samples.
- Lead the QC work stream of tech transfer and start-up of Cell Therapy products assuring the milestones of the project are reached.
- 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.
- Manage an effective QC documentation system. The QC Manager will prepare, review and approve documents as required.
- Ensure QC operation readiness for HA inspections (PAI, directed, other)
- Ensure the QC department is in an audit ready at all times for both internal and external audits (HPRA, FDA, corporate, customer).
- Actively lead and support major 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 annual budget for consumables, capital and headcount.
- As required, act as designee for the Quality Head, Cell Therapy in their absence as required.
- Participate as required in global project teams relating to QC and wider quality activities.
Requirements for Quality Control Manager:
- Degree in Science or other relevant field.
- More than 10 years’ experience in the Pharmaceutical/Biopharma industry and minimum of 3 years QC Laboratory Management experience
- Experience in Cell Therapy product testing would be advantageous
- Extensive experience of both chemistry and microbiological testing
- Experience in budgetary control and audit preparation
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Previous experience in managing the performance of individual team members and that of the overall team
- Knowledge and experience of Lean Laboratories is preferable
- Previous experience in setting up a new QC laboratory is desirable
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below