Senior Associate, Microbiology

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

• Conducting routine analysis of raw materials, in-process, finished product samples & stability study samples for Different Microbiological Test as per Good Laboratory Practice (GLP).
• Performing the Environmental monitoring.
• Documentation as per the Pharmaceutical regulations of various regulatory authorities and Preparing documentation of the in-house developed Microbiological methods, study protocols, standard testing procedures, specifications & method of analysis for routine used by QC personnel
• Coordinating with QA / QC personnel for implementation of the current / revised standard testing procedures, specifications and method of analysis.
• Scientifically sound / technical Writing skill for audit response to different regulatory agency and having the knowledge of different regulatory guidelines.
• To provide the training to Microbiologist on laboratory technique, quality control procedure & principles of GMP/GLP, Data integrity policy.
• Experienced in external & internal audits and ensuring effective implementation of CAPA related to different regulatory observation
• Conducting risk analysis for different microbiological processes.
• Knowledge of Quality Management System (Change control, Non-conformance, LIR, OOL etc.)
• Resourceful in Environmental Monitoring of clean room and contamination control strategy.
• Knowledge of microbiological Instrument/Equipment and Automated Microbiologic machines.
• Skilled in Track-wise system and in LIMS/MODA for the Environmental Monitoring
• Skill to build the inspection plans for various components proficiency in managing audits by US-FDA, ANVISA, EU-GMP, National GLP, MHRA and other Regulatory & Customer Audits.
  
  
  

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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