Job Description

This is where you save and sustain livesAt 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.Job Responsibilities:

• Prepare and review Environment Monitoring or HVAC qualification or requalification, supervising master protocols.
• Review the Annual calendar such as calibration and Performance Qualification (PQ) calendars.
• Review reports of microbiological qualifications related to HVAC.
• Prepare draft reply for International Regulatory Affairs (IRA) queries, EM regulatory observations, customer audit observations.
• Capture the abnormalities in the process, system, or documents and resolve them according to the Quality management system.
• Keep track of regulatory commitments and ensure timely fulfillment of the same.
• Review master drawing related to the facility or cleanrooms and process.
• Review the Standard Operating Procedure (SOP) according to the current regulatory requirements.
• Ensure a clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the standards and guidelines.
• Suggest effective Corrective and Preventive Action (CAPA) for the abnormalities observed and ensure its timely implementation.
• Carry out investigation in case of Out of specifications (OOS) or Non-conformity (NCR) or Laboratory Investigation Report (LIR) and take the corrective and preventive actions (CAPA).
• Support team in coordination with the technical department.
• Initiate and implement change control, wherever necessary.
• Ensure calibration and validation of instruments in the microbiological laboratory in coordination with Quality Assurance sub-department.
• Ensure the implementation of Good Manufacturing Practices and Good Laboratory Practices norms.
• Perform other periodic microbiological tests as per Standard Operating Procedure (SOP).
• Prepare and review EM/water trends periodically.
• Attend national, international, and residential trainings to update self.
• Ensure qualification (Gowning or Analyst) of personnel entering cleanrooms.
• Assist Microbiology Head regarding the validations done and routine observations related to the Environment Monitoring Program.
• Support the team for cross-functional coordination and resolution of operational issues.
• Report operational issues to the Microbiology Head in their absence.
• Approve certificates received from third parties regarding calibration, validation, materials, and testing in consultation with Microbiology Head.
• Bring to the notice of Microbiology Head any abnormalities in the clean room or manufacturing areas and ensure the implementation of preventive and corrective measures.
• Intimate the Microbiology Head about any failures in EM and water.

Job Requirements:

• Bachelor's degree in Microbiology, Biotechnology, or a related field.
• Minimum of 5 years of experience in a similar role within the pharmaceutical or biotech industry.
• Strong knowledge of environmental monitoring, HVAC qualification, and regulatory requirements.
• Proven experience in Quality management systems and Good Manufacturing Practices (GMP).
• Excellent attention to detail and ability to identify abnormalities in processes, systems, or documents.
• Strong problem-solving skills and ability to suggest effective Corrective and Preventive Actions (CAPA).
• Good understanding of laboratory investigations, Out of Specifications (OOS), and Non-conformity (NCR) procedures.
• Ability to coordinate with cross-functional teams and resolve operational issues.
• Familiarity with change control processes and implementation.
• Knowledge of calibration and validation of instruments in a microbiological laboratory.
• Familiarity with Good Laboratory Practices (GLP) and microbiological testing procedures.
• Excellent communication skills, both written and verbal.
• Strong organizational skills and ability to prioritize tasks effectively.

About Baxter Healthcare Corporation:Baxter Healthcare Corporation is a world-class pharmaceutical company dedicated to improving the lives of people around the globe. We strive for exceptional quality in all aspects of our operations and are committed to manufacturing detailed products that meet the highest standards of safety and efficacy.At Baxter, we believe in the power of collaboration and inclusion. We foster a work environment where every individual is valued, and their unique perspectives and ideas are encouraged. Our ambitious team is driven by the desire to compete on a global scale and make a positive impact on the healthcare industry.Join us in our mission to determine the future of healthcare and successfully implement innovative solutions that improve patient outcomes. As a member of our team, you will have the opportunity to work with individuals who consistently demonstrate exceptional skills and contribute to the development of life-saving therapies.If you are a proven professional in the field of microbiology, passionate about quality, and dedicated to making a difference, we invite you to apply for the position of Supr, Micro EM at our Ahmedabad location.Please submit your application along with your updated resume and a cover letter highlighting your proven experience and why you are interested in joining Baxter Healthcare Corporation.We look forward to welcoming you to our team!Reasonable AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Baxter