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Stryker
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Senior Microbiologist

Senior Microbiologist

Stryker

0 years

0 Lacs

gurugram haryana india

Posted:1 day ago| Platform:

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Skills Required

testing monitoring effectiveness technology troubleshooting data reports audit drive compliance audits strategy support coordination communication trackwise management healthcare

Work Mode

On-site

Job Type

Full Time

Job Description

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:

Coordination, delegation, communication, stress, resiliency
Relentless Quality First
ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM)
SME core competencies
Product Cleanlines
Cleanroom/ Environmental Monitoring/ Testin
Sterilization (EO)
English and German or French

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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Stryker

Medical Technology

Kalamazoo

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Senior Microbiologist