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

📌 Formulation Documentation Borivali
🏢 Approach
📍 Borivali