- Assist in the execution of process technology transfers and Commercial batches at manufacturing sites (in-house and CMO).
-
Conduct scale-up, exhibit batches and commercial batches under supervision, ensuring proper documentation and parameter tracking.
-
Support in the preparation and review of Batch Manufacturing Records (BMRs) and commercial 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 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.
Education: M.Pharm
Experience: 5-8 Years in manufacturing of Commercial validation batches and commercial launch with USFDA, EU, MHRA, ANVISA requirement etc.
Technical Skills: Expertise in preparing and reviewing regulatory documents and reports, Strong understanding of data management and documentation tools,
Soft Skills: Excellent written and verbal communication skills, Problem-solving mindset and proactive approach to challenges, Ability to work independently and as part of a team, Strong attention to detail and organizational skills
