About this role
Job DetailsJob Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Job Shift: Day
Assist the execution of commercial launches and process validation batches at manufacturing sites (in-house and CMO).
Execute scale-up and exhibit batches under supervision, ensuring proper documentation and parameter tracking.
Support in the preparation and review of Batch Manufacturing Records (BMRs) and validation protocols/reports.
Coordinate with R&D, QA, QC, Regulatory Affairs, and Manufacturing teams for effective knowledge transfer and execution.
Participate in process investigations, troubleshooting, and deviation handling during trial and commercial validation batches.
Assist in equipment selection and capacity assessment based on product-specific requirements.
Ensure document readiness for regulatory submissions, respond to technical queries, and support audit preparation.
Support internal and external/vendor audits by providing required documentation and technical inputs.
Prepare data summaries, technical reports, and presentations as per project or management requirements.
Maintain accurate records, follow applicable SOPs, and ensure strict GMP compliance in all operations.
QualificationsM. Pharma with 2-5 years of experience in execution of process validation batches
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