Respi CoE Analyst

• Key Accountabilities

• 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

• 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

• 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

• 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)

• 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

• 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

• Major Challenges

• 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

• Key Interactions

• 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)

• Dimensions

• 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

• Key Decisions:

• Finalisation of analytical method or any change in existing method to Group/Sub-Group Leader - Formulation ADL

• Skills & Knowledge

• M. Sc. (Analytical Chemistry) / M. Pharm.

• 2-4 years of experience in pharmaceutical organisation with knowledge of handling instruments like HPLC, GC, Dissolution tester and DPI related instruments
• Knowledge of current guidelines like ICH, EMEA, WHO

Cipla