Role & responsibilities

- Prepare/review PDRs and pharmaceutical development reports

- Compile pre-formulation, formulation and process-development data

- Document formulation optimization and development rationale

- Prepare/review QbD, QTPP, CQA, CMA, CPP and risk-assessment documentation

- Prepare/review MFR, BMR and Technology Transfer documents

- Prepare scale-up, optimization and technical reports

- Support CTD/Module 3 pharmaceutical development documentation

- Review formulation, analytical and stability data for technical reports

- Prepare scientific justifications and regulatory query responses

- Ensure traceability from experimental data observations conclusions development decisions

- Check consistency across development reports, manufacturing documents and regulatory documentation

- Coordinate with F&D;,



ADL, QA, RA, Project Management and Manufacturing

- Ensure timely completion and lifecycle management of R&D; technical documentation

Preferred candidate profile

- Robust Formulation R&D; fundamentals

- Excellent scientific writing and technical interpretation

- Knowledge of QbD and risk-based pharmaceutical development

- Understanding of scale-up and technology transfer

- Exposure to regulated-market documentation

- Strong data-review and critical-thinking ability

- Excellent attention to detail and document ownership

- Proficiency in MS Word, Excel and PowerPoint

📌 Executive - Formulation Development (Ambernath)
🏢 Ashish Life Science
📍 Ambernath