Job Description
My client a leading Pharmaceutical company now require a Senior Quality Control Manager to join their expanding team.
The Senior Quality Control Manager be responsible for the overall management of separate Quality Control laboratories supporting the manufacture of API, finished capsule product and biologics products. They will have the responsibility for all chemistry and microbiological testing activities on site.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Senior QC Manager
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 chemistry and microbiological samples.
Lead and participate in the Technical Transfer / Validation of new and existing processes.
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.
Prepare for, and support, 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 Site Quality Head in their absence.
Participate as required in global project teams relating to QC and wider quality activities.
Requirements of Senior QC Manager :
10 years' experience in the pharmaceutical industry and minimum of 5 years QC Laboratory Management experience
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