Job Description
The Microbiologist role is to conduct data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to both laboratory Technicians and various operations workstreams. The Microbiologist will be responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements
Responsibilities
- Demonstrate a primary commitment to patient safety and product quality.
Responsible for maintaining a full understanding and complying with all the regulations governing the quality system (including ISO 17025). - Ensure all training is completed as per Laboratory Training Program 90188455.
- Co-ordinate and train to ensure compliance to mandatory training requirements.
- Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
- Provide technical guidance/troubleshooting 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 requalification’s as assigned and write related protocols/reports.
- Provide direction to Technician roles and various operations workstreams.
- Attend and represent the Microbiology Laboratory at various meetings and on cross-functional project teams as required.
- Support Internal/External Audits and ensures all non-conformances are adhered to in a timely manner.
- Designee for Laboratory Supervisor as required, by overseeing the day to day operation of the Microbiology laboratory.
- Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
- Perform and assist with additional duties as may be directed by the Microbiology Supervisor/Manager.
- If Plant Microbiologist, additional key responsibilities include: Compile, Review and Report Environmental metrics; Calculate and review product bioburden alert limits and cleanroom air and surface alert and action limits; Establishes and monitors appropriate Lab Metrics including Management Review support; Review and Assess from a microbiology context all changes that impact product or the cleanroom environment including introduction of new products; Provides technical support on microbiology related issues to various operational department
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System
Qualifications and Experience:
- HETAC Level 8 degree (240 credits) in Microbiology or similar discipline.
- Minimum of 2 years experience in a similar role.
- Good technical capabilities in Microbiology, communication skills, teamwork abilities and initiative
- Knowledge of ISO 17025 would be beneficial
For further information on this QC Microbiology Analyst position please contact Gavin Kennedy at The RFT Group on 01 2302400 / gavin@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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