Job Description
My client a leading Pharmaceutical company now require a Quality Control Supervisor to join their expanding team.
The Quality Control Supervisor has an important role to play in the start- up of the laboratory in a new Biologics manufacturing facility and been 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 and it comes with a good salary with good benefits.
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.
7 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
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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