M Pharma Jobs: Hiring an Executive – FRD Non Orals in Baroda |
Apply for Sun Pharma Career
Are you a Pharma graduate looking for M Pharma Jobs? Sun Pharmaceutical Industries Ltd is hiring an Executive – FRD Non-Orals for its R&D unit in Baroda. This role involves designing and optimizing non-oral dosage forms such as microspheres, implants, and in-situ gels using the QbD approach. Ideal for M.Pharm professionals with 1–5 years of experience, the position offers an opportunity to contribute to advanced formulation research, regulatory documentation, and technology transfer in one of India’s leading pharmaceutical companies. Apply Now for Sun Pharma Career.
Job Details:
- Job Title: Executive – FRD Non Orals
- Location: Baroda (Tandalja – R&D)
- Business Unit: R&D1 Regulatory Affairs
- Job Grade: G12A
About the Company:
Sun Pharmaceutical Industries Ltd is the largest pharmaceutical company in India and one of the leading global specialty generic companies. With a strong commitment to innovation and excellence, Sun Pharma delivers high-quality, affordable medicines trusted by healthcare professionals and patients across more than 100 countries. At Sun Pharma, the culture encourages you to “Create your own sunshine” — fostering professional growth, innovation, and collaboration. Employees are empowered to take charge of their journey, continuously improve, and thrive in a supportive environment where everyone grows together.
Educational Qualification:
M.Pharm Graduate
Experience:
1–5 years of experience in formulation research and development (FRD).
Key Responsibilities:
- Design and conduct experiments for preformulation and formulation optimization of microsphere and long-acting complex non-oral dosage forms (implant, in-situ gel, etc.) using QbD (Quality by Design) principles.
- Execute experiments based on Design of Experiments (DoE) methodology.
- Conduct literature searches, prepare summary reports, and review ANDA projects.
- Develop product development study protocols and reports in compliance with regulatory standards.
- Record experimental details, observations, and test requests using eLNB/METIS software.
- Compile and interpret trial and stability study results using MINITAB software.
- Prepare Technology Transfer documents, including MF, Risk Assessment based on CPP & CQA.
- Draft justifications for import materials, documents for Form 29 applications, and Common Pharmaceutical Documents for DCGI submission.
- Execute scale-up and exhibit batches, preparing scale-up summary reports.
- Prepare Stability protocols as per regulatory guidelines.
- Develop Product Development Reports, risk assessments for elemental impurities, residual solvents, and extractables for regulatory submission.
- Prepare pre-ANDA meeting packages, scientific justifications, and reports for regulatory agencies.
- Write and review SOPs for laboratory equipment and instruments.
- Participate in equipment/instrument qualification activities during new procurements.
- Ensure compliance with internal quality systems during all activities.
- Coordinate with cross-functional teams including Analytical Development (ADD), Regulatory Affairs (RA), Corporate Quality Assurance (CQA), and Plant teams for project-related activities.
