Cadila Pharma

•	Major Purpose of the Job:
1.	Ensure the compliance of Qualification and Validation in Quality Management System as per current GMP regulation.
•	Principal Tasks: -
1.	Quality Risk Assessment.
2.	Qualification Activities (HVAC, Area, Equipment, Utilities & Misc.).
3.	Process Validation / Hold Time Study of Semi-Finished Goods.
4.	CSV Validation.
5.	Equipment Hold Time study.
6.	Out of Trend.
•	Responsibilities:
1.	Quality Risk Assessment; To coordinate, assessment & perform risk assessment of process, equipment, system etc. along with cross functional team, report compilation, verification of mitigation plan (if any).
2.	Validation & Qualification; Ensure validation & qualification state 24x7 for all process, equipment, system, utilities etc. Coordination with cross functional team, prepare/review respective documents, execution & monitoring of validation & qualification activities, compilation of report along with supporting documents, re-validation & qualification as per schedule, record management.
3.	Ensure Hold Time study of SFG, report compilation, notify any abnormal observation during study, and follow up with concern department for rectification of abnormal observations, record management.
4.	To review and update document as per regulatory guidelines.
5.	Evaluation of out of trend data based on APR, assessment & Investigation with cross functional department, monitoring for implementation of CAPA
6.	Review and compliance of annual product review.
7.	Review & approval of SOP of quality assurance.
8.	Any other job as and when delegated by Head QA.
•	Secondary Responsibilities:
1.	Cleaning Validation.
2.	Cleaning Validation Assessment Study for New product

Job Details

Skills Required

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