Purpose Statement

The purpose of the Microbiologist role is to conduct testing on routine and non-routine samples, data review, provide support and guidance in the areas of cGMP, Regulatory, technical investigations, test method validation and environmental control to Technician levels. They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Key Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025).
• Conduct testing according to written procedures.
• Responsible for reviewing all data and associated data reports generated in the laboratory for conformance to specifications.
• Ensure all training is completed as per Laboratory Training Program 92048659.
• Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner.
• Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
• Assist manufacturing/operations/quality personnel in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and Out of Specification results are documented and reported to Laboratory Management.
• Support Internal/External Audits.
• Provide direction to Technician I ,II & III roles.
• Maintain safety awareness in the laboratory.
• Represent the laboratory on cross-functional project teams as required.
• Designee for Senior Microbiologist /Microbiologist II as required, by overseeing the day to day operation of the Microbiology laboratory.
• Coordinate and/or perform method validations of new products.
• Assists in the implementation of new tests, new technology, and improvements to existing tests.
• Perform new equipment qualifications and requalification as assigned and write related protocols/reports.
• Documentation control – coordinates and updates documentation within the laboratory to ensure all documents are controlled in line with requirements.
• Coordinate and train to ensure compliance with mandatory training requirements.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Sn Microbiologist.
• Assist in writing and updating Procedures, Work Instruction.
• Assist and Perform the Audit Preparation Internal and External.
• Support for the Analytical Lab if required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Perform and assist with additional duties as may be directed by the Senior Microbiologist /Microbiologist /Lab Manager.

Requirements

Minimum Degree in Science in Microbiology / Biotechnology / Chemical / industrial science or equivalent field
Open for Fresh Graduate / minimum 1-2 years experience
Required skills

Microbiological Laboratory Skills, Analytical Skills, knowledge in Microbiology Medical device testing