Overview
Team Member MSAT Injectable Jobs in Greenlawn, USA at Dr. Reddy’s Laboratories Ltd
Job Description
- To handle the cleaning Validation activities for Injectable manufacturing lines.
- Preparation & revision of CVMP.
- Updating and Approval of CV Matrix.
- Preparation and Review of Cleaning Validation related Checklists, Protocol and Reports and its related assessments/training (as applicable).
- Implementation of new applications related to Cleaning Validation.
- Provide support for troubleshooting, root cause analysis and product impact assessments for non-conformance investigations and process changes/improvements.
- Support for regulatory audits.
- Initiation, review and approval of Change controls, Incidents, Process comparison and risk assessment with respect to Validation / qualification activities.
- Co‑ordination with CFTs (i.e. Production, QA, QC) for tracking and execution and various documentation.
- Training of employees.
- Review change controls.
- Prepare, review, and approve technical protocols, reports, and product impact assessments related to product lifecycle management (LCM).
- Initiate, change controls, incidents, and risk assessments related to technology transfer activities.
- Support technology transfer activities for new products, scale‑ups, line transfers, and site‑to‑site commercial batches for injectable products.
- Support investigations for non‑conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
- Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
Qualifications
Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy, 4 to 8 years of relevant experience.
Benefits Offered
The benefits you will enjoy dy’s are on par with best industry standards. They include, among other things, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself.
Dr. Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour, religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
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Title: Team Member MSAT Injectable
Company: Dr. Reddy’s Laboratories Ltd
Location: Greenlawn, USA
Category: