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The person will be responsible for the execution and analysis of analytical work (Method development, and development stability sample analysis) performed at Analytical Development Laboratory, Research & Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites.
Quality:
To understand the project in the guidance of Sub-department Manager and follow their instructions.
To perform the analysis under the supervision of Sub-department Manager.
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if
any deviation or issues are observed.
To operate and calibrate the instruments as per approved standard operating procedure.
To keep track of each activity related to product analysis and development activities.
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle
and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.
To make entry in respective logbook, when start the analysis and at completion of analysis.
To use live reference standards and working standards for analysis and maintain their records.
To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
To follow the Good Documentation Practices.
To update the Development stability compilation sheet after the review of the ELN.
To investigate if any deviation / abnormal observation in term of results and report to Sub-department
Manager.
To check the trend of results before reporting the results.
To keep the status of daily work and report to Sub-department Manager on daily basis.
To check Preventive Maintenance, Breakdown maintenance and perform risk assessment and
suggest immediate corrective actions as an when required. To report conclusion of preventive
maintenance and breakdown maintenance to Sub-department Manager.
To keep track of regulatory commitments.
To use standard formats for documentation.
To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.
To list out all resources required for the study and keep track of routine requirements and ensure
timely procurement of the same, verify the materials received for analysis from supplier as per given
requirement.
To verify the instruments after the maintenance.
To complete the trainings as per the quality matrix targets.
To prepare and update the SOPs. To prepare method development and verification report.
Administrative:
To perform the work as allocated by Sub-department Manager.
To liaise with customers, staff and suppliers.
To write / fill the record in legible writing.
To keep the documentation online with analysis.
To compile required data for Management Information System and provide to Sub-department
Manager.
In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.
To perform the documentation and QMS related activity using applications software like TCU,
Trackwise, etc.
Communication to the management / superiors:
To communicate about any failure or abnormal notification or non-complies results to Subdepartment Manager for their attention and seeking for the solution.
To communicate project related issue to Sub-department Manager and follow the action plan.
To keep status of daily work and report to Sub-department Manager on daily basis.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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