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 (India)
🏢 Approach
📍 India