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- 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.
Assoc, Quality Control - Ahmedabad, India - Baxter
Description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.