This position reports to the Manager in the Microbiology Laboratory of Biotechnology Facility.
WHAT YOU WILL DO
Responsibilities include, but are not limited to:
•Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. Compressed air and Nitrogen systems.
•Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test.
•Perform personnel qualification and re-qualification and also to lead qualification and re-qualification of the clean rooms, when necessary.
•Provide testing support to plant validation activities
•Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi-finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate.
•Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
•Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
•Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
•Perform microbial identification (Bacteria, mold and yeast) in water, environment and product samples.
•Perform periodic review of closed out Validation Document packages and Standard Operating Procedures.
•Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior, Lead Microbiologist, Sr/ Manager, Microbiology.
•Liaise with external vendors on instrument calibration and maintenance.
•Solicit quotations of laboratory consumables.
•Maintain continuous supply of laboratory consumables
•Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
•Supervise and oversee Third Party Contractors, where applicable
•Liaise with other department for training needs and technical support
•Liaise with vendor and service engineers/ESPs for equipment validation, calibration and maintenance work.
•Need to coordinate with suppliers of microbiological media and other equipment.
•Need to coordinate with Quality, respective Plant operations, Projects and Engineering & Maintenance
•Any other duties as assigned by the Supervisor/ Manager
WHAT YOU MUST HAVE
To be successful in this role, you will have:
Qualifications:
• Degree in Microbiology / Science (general) / related Engineering field
Required Skills / Experience / Competencies:
• Good understanding of Safety and cGMP practices
• Computer Literacy
• Good oral and written communication skills
This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.
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