Team Member - MSAT

Job Summary

We are seeking a Technology Transfer team member to support the development and implementation of robust manufacturing processes including authoring validation protocols and reports conducting risk assessments and utilizing advanced tools for process monitoring and analysis. Your role will involve active participation in technology transfers continuous improvement initiatives and ensuring compliance across manufacturing operations.

Roles & Responsibilities

• Responsible for Validation which shall include: Preparation/Review/Approve of MPR. Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report.
• Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities. Execution of Tech transfer products at Receiving Units. 
• Responsible for QIP which shall include: Identifying root cause for QIP. Execution of QIP. Conclusion/Recommendation of QIP.
• Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT.
• Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements.
• Follow up & coordinate with cross functional team for execution of validation.
• Give the input for the monthly reporting system participate in the internal & external audits present the documents to auditors/inspection team.

Qualifications :

Educational qualification: Masters/Bachelors/Ph.D in pharma

Minimum work experience: 6-8 years of experience in Process development / MSAT / Tech transfer

Skills & attributes:
Technical Skills

• Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (OSD)
• Experience in process Engineering Quality by Design (QbD) principles and risk assessment approaches. 
• Knowledge of International Council for Harmonization (ICH) guidelines related to Product development or Process Development.

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.

Remote Work :

No

Employment Type :

Full-time