• Associate Manager , R & D - Stability Jobs in Ahmedabad,India - 23847791

  • Baxter India Pvt Ltd

Job Description:

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 (ie 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

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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_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Apr 2020

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