Research Analyst - FADL

Job Objective:

To enable establish QC efficient methods and processes for assigned products by performing analytical research activities while adhering to regulatory norms and established SOPs 

Job Responsibilities

Analytical Method Development

• Assist the supervisor and team leader in conducting literature review by reviewing documents such aspharmacopeia, research available in public domain, etc. 
• Conduct analytical procedures by following the trial and error methodology prescribed by Supervisor/ Team Leader to assess the workability of the proposed analytical method 

Analytical Method Validation and Method Transfer as per cGMP

• Check availability of required equipment and materials as per the method validation checklist and highlight if any discrepancies/shortfalls to enable validation exercise to be conducted as scheduled
• Prepare method validation/ qualification protocol by planning activities and obtaining acceptable limits for tests Perform the validation exercise as per work plan (in accordance with protocol) and draft the report
• Report any discrepancies in the results to the supervisor in a timely manner Conduct/perform the method transfer at the plant by guiding the plant QC.
• Investigate concerns if any and help plant QC in preparing the final report 
•  Ensure availability of working and reference standards by maintaining required quantity and records, and intimating CPRL when the quantity is low
• Generate standards by doing sample analysis/characterization and preparing analytical data sheet 

Documentation

• Record the raw data contemporaneously (as it happens) in form of observations/reports and communicate to the supervisor/TL
• Assist in preparation of Standard Analytical Procedures (SAP) document.
• Prepare ARL related documents for regulatory submissions
• Prepare method transfer protocol to enable transfer of methods to plant

Regulatory compliance

• Adhere to regulatory, cGMP, SOPS and safety guidelines for all processes
• Calibrate all instruments as scheduled
• Ensure data integrity in all respects
• Conduct specified tests and prepare relevant documents to aid supervisor/team leader in resolving internal/external audit queries Initiate incidence investigation