Executive - FRD Non Orals

Job Title

Executive – Formulation Research & Development 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.”

J ob Description

• To do Literature search & prepare summary report.
• To request/generate RM code, project code, product code.
• To apply for licenses for import of API/Innovator sample, for manufacturing license for examination, testing & analysis of drug products.
• To initiate procurement of raw material (API/Excipients), packing material & innovator samples in consultation with packing/purchase department.
• To prepare batches for pre-formulation, prototype, stability & method development & validation.
• To enter experimentation details in Log book/ELN.
• To prepare product development protocol for different development studies as per checklist, its execution & preparation of report.
• To prepare test request for analysis of raw material (API/Excipients) & drug product.
• To prepare stability protocol & submit samples to charge on stability.
• To prepare tech-transfer documents (e.g., Sheet II, MF, RA, FMEA, stability plan & SDS).
• To supervise scale up / exhibit / clinical batches at plant/CMO.
• To prepare documents required for regulatory submission for all markets & to prepare technical reports/scientific justification to respond regulatory queries.
• To propose in-process & finished product specification
  
  

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure : 0 – 4 yrs.

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

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)