MSAT Specialist

• 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.
• Coordinate with cross-functional teams for execution and documentation of new products, scale-ups, and line or site transfers.
• Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
• Preparation and review of Cleaning Validation and process related documents (Protocols, Reports, Master Plan and Assessments etc.)
• Preparation and review of CPV schedule and reports.
• Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
• Collaborate with cross-functional teams to improve manufacturing processes
• Conduct data analysis to identify trends and opportunities for process improvement
• Assist in the implementation of process improvements and new technologies
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements Include in the identification of the Root cause analysis for any OOT / OOS of the Products introduced at sterile facilities till Process validation.
• Support for Regulatory filings and Compliance issues for Sterile injectable products.
• Support for Regulatory audits.
• Absorb and transfer the products from the transferring site to FTO-11 and other sterile facilities with Pro-active approaches and risk mitigation strategies.

Qualifications

Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy

Additional Information

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 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy's 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. Reddy's why they come to work every day and they'll say, because Good Health Can't 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 we're 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 https://careers.drreddys.com/#!/