Job Description
Our client, an FDA regulated manufacturing company based in Galway, now seek a Microbiologist, Subject Matter Expert who will be designee for Laboratory Supervisor as required, by overseeing the day to day operation of the Microbiology laboratory.
The successful candidate will provide leadership and supervision to team members to maintain safety awareness in the Laboratory and ensure that all testing is carried out in line regulatory compliance in Microbiology to cGMP's of all regulatory agencies (including FDA, etc.).
This hire will provide expertise to support functions on Microbiology related issues (e.g. regulatory requirements, microbiological impact of product/process changes, product endotoxin, product Bioburden).
Additionally this hire will conduct data review, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams.
Responsibilities of Microbiologist, Subject Matter Expert:
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).
Requirements for Microbiologist, Subject Matter Expert:
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.
Previous experience in mentoring, training and developing Microbiology lab personnel would be ideal.
Good technical capabilities in Microbiology, communication skills, teamwork abilities and initiative
Excellent interpersonal and communication skills with good leadership abilities.
Please phone Larry on +353 1-2302400 / 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
Follow us on: Facebook, Linked-in, twitter