Baxter looking for Quality Control Associate

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.

Post : Assoc, Quality Control - QMS

Job Description
• 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.

Candidate Profile
• M.Sc / M.Pharm / B.Pharm
• Candidate must have 3 - 6 yrs. of working experience in QC department (i.e. pharma industry)

Additional Information
Qualification : M.Sc / M.Pharm / B.Pharm
Experience : 3 - 6 yrs
Location : Ahmedabad, Gujarat
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Control
End Date : 30th October, 2021