Senior QC Microbiology Analyst
|Contact Name:||Larry O’Leary|
Our client, a leading Biopharma company based in Dublin, now require a Senior Microbiology Analyst to join their expanding team. This hire will act as designee for the Plant Microbiologist in their absence. This is a permanent role; with generous salary with benefits package.
The Senior Microbiology Analyst will oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of biologics product.
This Senior hire will schedule microbiologists work and oversee aseptic practices (gowning, monitoring, cleaning and related training), plus provide training and development of microbiology analysts.
Responsibilities of Senior QC Microbiology Analyst
Responsible for oversight of the Microbiology laboratory supporting the manufacture of a biologics product.
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.
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.
Participate as required in global project teams relating to Microbiology and wider quality activities .
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 GLP / GMP 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.
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
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.
Requirements of Senior QC Microbiology Analyst:
Degree in Microbiology or other relevant field
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.
Experienced in oversight of more junior microbiologist, including their training and development in a GLP / GMP environment.
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
Please phone Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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