Team Member MSAT Injectable

• 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 comparision 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

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at  Work :

No

Employment Type :

Full-time