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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Requirements:
To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias
To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions wherever necessary
To guide and support team members for performing all test for in-process product & finish product as per the specification and schedule
To train team members on current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) with support from Sub-Department Manager
To prepare SOP as and when required
To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule
To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department