About the Company
Baxter one of the top Pharmaceutical and medical devices company, with the head quarters located in Illinois. Primary focus of treatment for the company is in the area of Hemophilia and in treating the immune and chronic medical conditions. The firm relieves the issues for millions of patients across the globe serving to the man kind from more than 85 years.
In the year 2018 Baxter was awarded for the best place to work globally. The company have the portfolio of medicines in Critical care, Nutritional, renal care, surgical and Hospital care. Apart from the pharmaceutical medicines the company also provides medical devices and infusions.
About the Job
Location of the Job
Ahmedabad
Quality assurance
Role
Handling of NCR/ investigation, Change control, CAPAs. and maintenance of Equipment & Utility (HVAC, Water System, Compressed Air, Nitrogen & Pure Steam) Qualification,
Risk Assessment and Cleaning & Process Validation,
Temperature mapping of all controlled Areas in facility and Equipment & Chambers, Sterilization.
Able to handle Greenfield/Brownfield & modification enhancement projects.
Handling the Regulatory Audit handling & Inspection Readiness
Quality Control
Follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC.
Able to review results of the tests against the specification & standard test procedure performed by team members.
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines.
Necessary in ensure that preparation of reagents and volumetric solution and standardization on time.
to perform Method Transfer study/Method validation/ verification as per approve protocol.
Handling and to Execute the work allocated by supervisor in shift and ensure it complete within timeline.
Required to Participate in 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.
Able to guide and support team members for performing all test for in-process product & finish product as per the specification and schedule.