Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
https://www.youtube.com/watch?v=X0h_0ih8MgQ
- To ensure the resources (manpower, instruments etc) are being utilized properly to meet the requirement of exhibit & commercial stability analysis.
- Ensuring the proper planning of the exhibit & commercial stability samples for the analysis as per stability schedule.
- To ensure and monitor the GLP/GMP activities in exhibit & commercial section.
- To escalate the failures related to commercially distributed batches to the management within the timeframe.
- Verification and review of the stability protocols as per respective country requirement/commitments to the agency for conducting the stability of products.
- Responsible for the completion of Stability Study of exhibit & commercial products as per laid down procedure
- Abnormal stability trends identification for exhibit & commercial products during analysis of stability samples (i.e. Commercial).
- To ensure timely escalation of out of specifications and out of trend results to department head.
- To review the commitment note for stability study as per IRA requirment.
- To ensure timely review and closure of investigation of OOS/OOT /LIR and deviations related to commercial stability.
- To ensure timely initiation and closure of identified CAPAs arising from any investigation are implemented within the time frame.
- To ensure the completion of the stability sample analysis with cGMP requirement without any data integrity observations.
- To review the analytical method transfer protocol & reports as per laid down procedures.
- To ensure the availability of chemicals, columns, standards required for method transfer activity.
- To notify any concerns observed during method transfer acitivity to management.
- To ensure the authorisation of analysts with relevance instruments.
- Ensure the GDP practices while review of analytical raw data.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Get email alerts for the latest"Associate Manager, R&D - Stability jobs in Ahmedabad"
