To assist in the design, development, and documentation of new and existing formulations, and to prepare technical documentation required for regulatory submissions and product transfers.
Key Responsibilities
Prepare and maintain Formulation Development Reports (FDRs) and Product Development Reports (PDRs)
Compile data for CTD Module 3 (Quality) in coordination with Regulatory Affairs
Support preparation of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
Document and interpret stability studies, analytical method validation, and process validation data
Support technology transfer to production units by providing technical documentation
Coordinate with RA, QA, QC, and Production teams for data collection and documentation
Prepare QbD/DoE reports, comparative dissolution profiles, and bioequivalence data summaries
Maintain archives of development documents as per GDP and regulatory guidelines
Assist in generating product justification and stability summary reports for submissions
Required Skills
Knowledge of formulation development (solid oral / liquid / semi-solid dosage forms)
Familiarity with ICH guidelines and CTD structure
Proficiency in MS Office and technical report writing
Understanding of stability study design and analytical interpretation
Strong collaboration skills with RA and QA departments
Key Competencies
Strong analytical and scientific thinking
Excellent technical writing and documentation abilities
Attention to detail with a compliance-focused mindset
Team-oriented, proactive, and deadline-driven
Job Type: Full-time
Pay: ₹18,359.71 - ₹40,215.47 per month
Benefits:
Paid sick time
Provident Fund
Work Location: In person
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