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Respi CoE Analyst

Respi CoE Analyst

Cipla

2 - 4 years

4 - 6 Lacs

Mumbai Nagpur Thane Nashik Pune Aurangabad

Posted:1 week ago| Platform:

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Skills Required

CRO Method validation Reverse engineering Formulation Pharma Stability studies Packaging GLP GMP HPLC

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Accountabilities

Accountability Cluster

Major Activities / Tasks

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

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)

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:

Decisions

Recommendations

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

Comments:

Skills & Knowledge

Educational qualifications:

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

Relevant experience:

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

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