Tanu Infotech employs diverse IT professionals with strong technology skills and business knowledge. Our mature methodologies and cost-efficient delivery model enable us to effectively handle software projects of any scale and complexity.
At Tanu Infotech we believe in delivering high quality & reliable solutions to complex business problem of clients globally with our innovative & highly professional methodologies. With our continued dedication we look to become a single stop shop for all the IT needs of our customers. Tanu Infotech Software Solutions is one of the leading offshore software development service providers, offering an array of IT related services to its clients across the globe. With sound domain knowledge we aim to deliver value to our customers through our innovative software solutions and services.
Job Description :
The MO (Microbial Out-of-Limits) Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence. The Investigator partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs. Interacts with all levels of staff and provides timely updates on investigation status. Manages several investigations at a time.
What you'll be doing
Determines scope, product impact, root cause, corrective and/or preventive actions of microbial excursions including surfaces, viable air, non-viable air, water, bioburden and endotoxin testing results
Expeditiously identifies potential root causes for excursions and immediate mitigation actions
Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
Closes investigations in a timely manner to meet business and compliance needs
Works with minimal supervision to drive investigations to closure
Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
Manages investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
Understands and implements procedures that support implementation of CAPAs
Presents and defends investigations during regulatory inspections, as required
What you'll bring
Bachelor or Master's degree in science in Microbiology or related field with 2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry
Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality
Strong communication and project management skills
Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
Must have strong technical writing skills and able to put complex thoughts and issues into writing in such a manner that can be understood by the reader
Must be able to interact with, and influence others at various levels in multiple departments
Must have knowledge of FDA quality systems regulations
Must have working knowledge of TrackWise system
| Suresh Gulimi Talent Acquisition Lead Mobile: Email: Tanu Infotech, INC
360 Bloomfield Ave STE 301 Windsor CT 06095
Staffing / Recruitment / Consulting / Offshore Minority and Women-Owned Business Enterprise ("MWBE") |
*** Tanu Infotech is Celebrating 10 years in IT Industry***
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