Executive - FRD Non Orals

Job Title :

Executive – FRD Non Orals

Business Unit :

R&D1 Regulatory Affairs

Job Grade

G12A

Location : Baroda

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job Description

• To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form (Implant, In-situ-gel, etc.) based on QbD approach.
• To execute the experiments as per Design of experiments
• To do literature search, prepare summary report and review for ANDA projects.
• To prepare product development study protocols and reports as per regulatory requirements.
• To enter the experimental details, observations and test request in the eLNB / METIS software.
• Experimental trials and stability study results compilation and interpretation using MINITAB software.
• To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP & CQA,
• To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission.
• To execute scale up / exhibit batches at plant and prepare scale up summary report
• To prepare Stability protocol as per regulatory requirement.
• To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission.
• To prepare pre-ANDA meeting package, scientific justification and / or report for various regulatory agency
• To prepare SOPs related to laboratory equipment / instrument.
• To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
• To comply with the internal quality system while performing any activity.
• To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Pharm

Experience

Tenure : 1-3 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!