Associate III, Design Quality

Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules. Having a good knowledge of product development and life cycle management. Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc. Having a good knowledge of regulatory requirements for ANDA/NDA submissions. Having good experience of responding regulatory queries. Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies. To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support. To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support. Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion. To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants. To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions. Quality SME for risk analysis of GPRD studies. To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc. To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice). To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices. To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts. To review ADL documents like specifications, method of analysis, method development, method validations, method transfer reports, stability sheets and ensure compliance as per ICH (International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and filing requirements as and when required. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. 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. Recruitment Fraud Notice Baxter 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 Recruitment Fraud Notice .