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Job Description
THE OPPORTUNITY
Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
WHAT YOU WILL DO
Main responsibilities are as follows:
• 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 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, lead qualification and re-qualification of the clean rooms, when necessary.
• Provide testing support to plant validation activities.
• Perform in-process and release sample 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 in 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 reviews.
• Writing/ revision of SOPs, protocols, test reports and any other work assigned by the Senior/ Lead Microbiologist, Senior/ Manager, Microbiology
• Liaise with external vendors on instrument calibration and maintenance.
• Solicit quotations of laboratory consumables.
• Maintain continuous supply of laboratory consumables.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Supervise and oversee Third Party Contractors, where applicable
• Coordinate with Quality, respective Plant Operations, Projects and Engineering & Maintenance.
• Liaise with other department for training needs and technical support.
• Liaise with vendor and service engineers for equipment validation, calibration and maintenance work.
• Coordinate with suppliers of microbiological media and other equipment.
• Any other duties assigned by the Manager.
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
WHAT YOU CAN EXPECT
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
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