Job for Associate Manager in R&D at Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Post : Associate Manager, R&D - Stability
• 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.
Req #: JR - 003766
Qualification : B.Sc, Advanced Degree / Ph.D
Location : Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Variations Support
End Date : 20th August, 2019
See All Other Jobs in our Database