Senior Executive-QA

Piramal Critical Care, Inc.On-siteFull-timeSenior, 5–8 yearsListed 1 month ago

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title
Senior Executive-QA
Job Description
QA professional experienced in GMP documentation, PPQ, SOP management, Cleaning Validation, and QMS activities including Change Controls, Deviations, CAPAs, customer complaints, and regulatory compliance.
- Review of executed BMR, ECR and Analytical Data.
- Review of BMR, ECR and SOP in Ensur Software.
- Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities.
- Preparation and Review of Annual Product Review.
- Preparation and review of SOPs.
- Handling Cleaning Validation.
- Handling Dispatch and line clearance activity.
- Handling of QMS related activities like Change Control, Event (Deviation/ Incident) and related CAPAs.
- Participate in handing of Customer Complaints, Return Goods and product recall.
- Evaluation of various QMS related activities like Change Control, Event (Deviation/ Incident).
- Any other work assigned by HOD.