Microbiology Analyst

Kenny Whelan And Associates

Limerick

Microbiology Analyst – Limerick. The Scientist 1 Micro and Scientist 2 Micro roles are responsible for assuring that non-conformance investigations, laboratory investigations and quality systems follow the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures. 2.Responsibilities: List main areas of responsibility: − Perform routine environmental monitoring, product testing in line with company and regulatory specifications and trend associated data. − Perform routine testing on water purification systems in line with company and regulatory specifications and trend associated data. − Perform Quality Control on incoming media and test kits. − Perform microbial identifications to ensure compliance with procedure and regulatory requirements. − Perform validation and annual re-qualification of production Sterilisers and calibration of Validation equipment and document-associated data. − Complete Annual re-qualification of laboratory Steriliser. − Perform Process / Equipment / Facilities and Utilities Validation and document associated data. − When required, Review and report Steriliser Non-conformances. − Perform monthly run review of production sterilisers performance using statistical tools. − Implement improved methodologies/processes for Lab processes. − When required Perform microbiology assessment on engineering changes. − Carry out safety inspections. − Training of new microbiology laboratory technicians. − Providing Japan Distribution with Sterility Certificates for product. − Ensure Lab is supplied with consumables. − All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform. − Creating, implementing and assessing change requests. − Sterilizing and disposing of laboratory waste. 3 . Education and Experience Required for Role. Essential: − Minimum of Certificate level qualification preferably in Microbiology or Biological Sciences. − At least 1 years industrial experience in the Pharmaceutical/Medical Devices Industry. − Good knowledge of FDA and ISO requirements. − Good organization skills and familiarity with computer packages. Note: Responsibilities and accountability will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description. This job originally appeared on RecruitIreland.com.

1841 days ago