Job for Quality Control Associate 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 : Assoc, Quality Control
• 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.
Qualification : B.Pharm, B.Sc, M.Sc
Location : Ahmedabad, GJ
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control
End Date : 10th October, 2019
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