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Assoc, Quality Control

1 month ago

Ahmedabad Gujarat, India BAXTER Full time

**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.
- To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
- To carry out the testing of Raw Material and Packing Material according to approved standard test procedure.
- To support Sub-Department Manager in releasing of Raw Material and Packing Material
- To carry out the calibration of instruments as per the schedule.
- To coordinate with stability department for the working standards as per the guidelines and various pharmacopoeias.
- To ensure the status label on the material and transfer such material in the respective area.
- To prepare reagent & volumetric solution and standardize it.
- To carry out all the necessary tests as per respective specification and procedure and record the results for all the materials.
- To check the stores and ensure the implementation of GMP norms in the stores.
- To inform to superior immediately in case of any Out of Specification result or Non-conformity or Laboratory Incident observed or any instrument breakdown.
- To review the sampling activity of all the materials performed by team members.
- To assess the results of testing of Raw Material, Packing Material 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 ensure availability of the working & impurities standards as per various pharmacopoeias.
- To ensure the status label on the material and transfer such material in the respective area.
- To support Sub-Department Manager, in investigation of out of specification (OOS), non-conformity and Laboratory Incident Report (LIR) and take corrective and preventive actions.
- To check and verify standardization and preparation of reagents and volumetric solution.
- To review periodic observation of retained sample done by team members
- To follow and ensure Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Documentation Practices inside QC.
- To support & guide team members in implementing change control, Corrective and preventive actions (CAPA) and check effectiveness of CAPA, give suggestions form Divisional Head if required.
- To train team members on current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices.
- To assist Sub-Department Manager in formation of SOP and give suggestions to improve system performance.
- To check, verify and review the calibration of all the analysis instruments whether performed as per the schedule.
- To ensure recording of all the data related to the testing online, on day-to-day basis and ensure traceability of the same.
- To check completion of method transfer successfully in coordination with Analytical Development Lab (ADL) Department

**Reasonable Accommodations**

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