Job Description
Our client, an FDA regulated manufacturing company based in Galway, now seek an experienced Microbiologist. This hire will be designee for Laboratory Supervisor as required, by overseeing the day to day operation of the Microbiology laboratory.
The successful candidate will represent the Microbiology Laboratory at various meetings and on cross functional project teams as required and will be responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements
(including FDA, etc.).
Additionally this hire will conduct data review, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams. Also, this hire will perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
Responsibilities of Microbiologist:
Co-ordinate testing and train to ensure a high Quality and Compliance awareness in the Laboratory.
Ensure compliance to all Laboratory and relevant plant wide procedures and practices.
Provide technical guidance/trouble shooting in the event of Microbiology related issues.
Assists in the implementation of new tests, new technology, and improvements to existing tests.
Perform new equipment qualifications and requalifications as assigned and write related protocols/reports. Maintain Microbiology in a state of audit readiness and represent Microbiology in external audits.
Co-ordinate validations of new products and Controlled environments.
Attend and represent Microbiology at meetings and project teams.
Responsible for maintaining a full understanding and complying with all the regulations governing the quality system (including ISO 17025).
Provide expertise to support functions on Microbiology related issues (e.g. regulatory requirements, microbiological impact of product/process changes, product endotoxin, product Bioburden).
Requirements for Microbiologist:
Bachelor's Degree qualification in Microbiology or related discipline.
3+ years work experience with a GMP environment, ideally as a Microbiologist in a FDA regulated environment.
Endotoxin testing and environmental testing essential.
Equipment qualification and calibration highly desired.
Previous experience in mentoring, training and developing Microbiology lab personnel would be ideal.
Excellent interpersonal and communication skills with good leadership abilities.
Please phone Larry on 01-2302400 / larry@rftgroup.ie
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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