Documentation Management
- Prepare, review, and maintain formulation development documents, protocols, reports, and records.
- Draft and update Master Formula Records (MFR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR).
- Maintain laboratory notebooks, product development files, and document revision histories.
- Ensure documentation complies with GMP, GDP, SOPs, and regulatory requirements.
Formulation Development Support
- Coordinate documentation related to formulation trials, optimization studies, scale-up batches, and exhibit batches.
- Compile formulation development data and prepare technical reports.
- Support technology transfer documentation from R&D to manufacturing.
Regulatory Documentation
- Prepare and compile documents required for CTD/eCTD submissions.
- Assist in preparing Product Development Reports (PDR), Pharmaceutical Development Reports, and other regulatory documents.
- Support responses to regulatory queries related to formulation documentation.
Cross-Functional Coordination
- Coordinate with R&D, QA, QC, Production, Regulatory Affairs, and Technology Transfer teams.
- Ensure timely availability and approval of documents for product development activities.
- Support validation, stability studies, and process documentation.
Compliance & Record Management
- Maintain document control systems and ensure proper archival of records.
- Ensure all documentation follows ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Participate in internal audits and ensure documentation readiness for regulatory inspections.
Pay: ₹20,000.00 - ₹25,000.00 per month
Work Location: In person
