Senior Microbiologist

What you will do :

• Coordinates microbiological and / or chemical testing, release of product and testing for validation protocols.
• Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests.
• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
• Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
• Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs / bioburden Monitorings
• Coordinates microbiological and / or chemical testing
• Review and approval quality records / validations
• Troubleshooting / NC Handling / Supplier Management / communication
• High Quality in Micro & Sterility
• Perform Monitoring Oversight / Data Trending
• Procedure Owners to Drive CAPAs / Improvements
• Reg. Compliance (Internal / External Audits, Tech Files, Standards, ISO 19227, law, GMP)
• Process Control / Validation Strategy for Micro / Cleaning / Sterility
• SME for Major Changes / PT (GIA MicroBio) + Support NPI / monitoring devitations / alerts / action limits / NC / CAPA

What you will need :

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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Skills Required

Change Management, Gmp, Capa, trackwise , chemical testing , Environmental Monitoring