Respi CoE Analyst

Accountability Cluster

Major Activities / Tasks

1. Develop new analytical methods for analysis of routine as well as stability samples by following proper GLPs to provide results or information regarding products to formulators

• Perform part method validation, forced degradation studies, excipient compatibility studies, reverse engineering, add-mixture studies, in-use studies, hold-time study and analysis of routine & stability studies
• Conduct cleaning validation studies
• Perform analysis of API, excipients and secondary material (packaging material, ink, adhesive etc.)
• Develop cost effective & time saving analytical method for  new or existing product
• Evaluate the pharmacopeia and verify the documents

2. Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation

• Maintain the lab instruments / equipment and troubleshoot the issues
• Perform calibration (schedule / breakdown) and calculate instrument utilisation
• Up-keep the HPLC/GC/IC columns as per cGLP

3. Document and interpret the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms

• Record and document all analytical activities in timely manner in Lab note-book, instrument/equipment and column log book
• Provide base documents for MOA / COA preparation for better coordination in analytical studies

4. Provide support to units or CFTs for transfer of analytical methods and techniques by visiting and demonstrating them with the relevant analysis to ensure successful and timely transfer of products

• Transfer methods and technologies to other units and departments
• Study the literature to resolve units and regulatory queries and conduct investigation studies in stipulated time period
• Analyse samples at pilot plant and unit for trace determination (Cleaning Validation)

5. Maintain proper safety, GLP, and GMP environment in the work place to minimize accidents and incidents

• Follow safety guidelines by ensuring use of PPE & MSDS of chemicals at time of analysis
• Upkeep the samples given for analysis and ensure timely destruction after analysis as per SOP
• Dispose solvents and waste generated during the analysis

6. Review the analytical requirements and recommend corrections in specifications by coordinating with units and CFTs to ensure smooth operations

• Arrange analytical requirements like column, impurities, standards, placebo and samples for units and other department like Validation Lab or Outsourced Lab
• Review and recommend corrections in the MOA, COA & Specifications

• Delay in developing analytical method due to unavailability of HPLC/ GC columns, reference impurities and specific instruments. Overcome by prior planning and by using alternate resources
• Additional or rework due to frequent changes in project priorities. Overcome by proper planning

Internal

External

• Formulation R&D for improving the quality of product (Daily)
• Loan Licence Team for analytical requirements which has to be provided (Weekly)
• Units for execution of project in unit (Twice a week)

• CRO for outsource analysis, validation, verification, release etc. (Twice a week)
• Service Engineers for breakdown of equipment and instruments (Fortnightly)

• Average number of projects : 8 (FY2016-17)
• Average number of analytical method developed : 10 (FY2015-16)
• Average number of part method validation : 7 (FY2015-16)
• Average number of method transfers / unit queries : 2
• Average number of additional projects: 4 (e.g. CIP, CHC, POC, etc.)
• Average number of Tec Mar studies completed : 10 per year
• Average number of new monographs evaluated : 10 per year