Cadila Pharma

Principal task and Responsibilities:
1) Daily analytical work plan & distribution to respective scientists
2) Monitoring Analytical method development, Validation study and method transfer activities.
3) Review the analytical method development data, validation study data and method transfer
protocol and reports.
4) Preparations of justifications
5) To maintain and observed GLP in working environment.
) Investigation Study as per requirement
7) Response and work plan for Customer & Regulatory Queries.
Responsibilities:
1) Oversee the department requirements
2) Ensure the qualified people are recruited and placed at the right position.
3) Oversee the budgetary preparation process for the department
4) Prepare the project timelines for the Analytical departments and Quality requirement
5) Provide strategic leadership for efficient and effective execution of projects
6) Evaluate the new projects and provide the required information to the management
7) Evaluation of Genotoxic impurities as per ICH M7 guideline
8) Participate in the teleconference and clarify the client's technical issues
9) identify the needs of training and send the analyst for training.
10) Ensure the maintenance of all the analytical equipment's on regular basis
11) Review the developmental reports for the accuracy and clarity
12) Train the department person to adhere the company value systems
13) To ensure smooth day to day operation of analytical and quality control labs
14) Ensure the testing performed using the proper procedures especially during development stage
15) Development of analytical methods by QBD concept
16) Doing Risk assessment for the elemental impurities as per ICH Q 3(d)
17) Investigations for the failures during the analysis to find and address the probable root cause
18) Technology transfer (direct & indirect) to respective sites ADL /QC
19) Method development for impurity isolation and purification of AP?s by preparative HPLC and
Mass Triggered Auto purification system.
20) Review of analytical method validation protocol & reports, analytical test reports and other
justification reports.
21) Trouble shooting and solving analytical related problems.
22) Responsible for stated activities of the Analytical development department which includes
qualification, calibration of analytical method and instruments, development of analytical methods
for various Analytical techniques, improvement in existing analytical methods.
23) Ensuring compliance to GLP and procedures in every section of the department.
24) Daily work planning and distribution to subordinates and Training of personnel
25) Taking care of Analytical HPLC Spare.
26) Maintain records for all analytical reports by entering all the data and timely release the
analytical reports to conccrn dept.
27) Taking care of all sophisticated Instruments.
28) Maintain Coordination with synthetic scientists during process development, optimization and
validation stages.
29) Maintain Coordination with Plant site during Method transfer activity.
30) Preparation of Weekly & monthly reports

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