Role Summary:
* Our client based in Co. Waterford is looking for a QC Microbiologist to join their busy biopharmaceutical facility.
* The function of this position is to provide microbiological support and knowledge to the micro team and to other departments.
* This position also includes performing microbiological testing as required by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
* The microbiology team is highly flexible and provides cross functional support.
* This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.
* This will be a 24/7 shift role (2 days followed by 2 nights then 4 days off) and overtime may be required.
Core Duties and Responsibilities:
* Provide microbiological support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
* Documentation review and batch release review.
* Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with the Microbiology, Validation, Manufacturing, Planning and Quality Assurance.
* Execution of QC-Micro testing (water sampling, water testing, growth promotion, identifications, Sterility testing, Environmental monitoring and plate reading) as required.
* Compliance with cGMP and Standard Operating Procedures at all times.
* Actively contribute to continuous improvement initiatives in the lab.
* QC Micro representation at cross functional meetings.
* Providing audit support for tours and presentations as required.
* Supporting projects as required.
* Conduct duties in a safe manner and report all safety issues or concerns.
Minimum Qualifications and Experience:
* Degree in Science or related area (Microbiology, Biotechnology, Pharmacy, Chemistry or Biochemistry preferred)
* Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo
* Understands Key Performance Indicators
* Knowledge of quality management systems (e.g. Veeva / Qualipso)
* Knowledge of lab management systems (e.g. LUNA)
* Be a motivated, ambitious and goal-oriented individual.
* 2-3 years working within Microbiology in a Pharmaceutical/GMP facility, ideally part of which would be in microbiology or a lab environment would be an advantage
* Experience in performing plate reading, water testing, endotoxin testing, sterility testing, requalifications, or knowledge of use and maintenance of microbiological equipment would be an advantage.
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