Lead QC Analyst - Microbiology
|Contact Name:||John Reid|
My client a leading Pharmaceutical company now require a Lead QC Analyst - Microbiology to join their expanding team.
The Lead QC Analyst - Microbiology will oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of biologics product.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Lead QC Analyst - Microbiology
Responsible for oversight of the Microbiology laboratory supporting the manufacture of a biologics product.
Oversee aseptic practices (gowning, monitoring, cleaning and related training).
Perform microbiological testing as required to support operations.
Perform environmental monitoring as required to support operations.
Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
Implement and maintain standards of clients and analytical practice consistent with current regulatory expectations.
Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
Training of microbiology analysts
Scheduling of microbiologist work via visual management
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
Oversee the environmental monitoring programme for the facility.
Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
Oversight of contract testing laboratories associated with microbiological 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.
Manage an effective laboratory documentation system. Prepare and review documents as required.
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.
As required, act as designee for the Plant Microbiologist in their absence.
Participate as required in global project teams relating to Microbiology and wider quality activities.
Requirements of Lead QC Analyst - Microbiology:
Degree in Microbiology or other relevant field
A minimum 4 years' experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
Thorough knowledge of GMP and current FDA & EMEA regulations
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new Microbiology 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