Title:  Executive - FRD Orals

Job Title:

Executive – Formulation Research & Development 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 Summary:-

·         As a Central Investigation Team member, primary role is statistical analysis of manufacturing data for the probable root cause and for other technical issues at site.

·         Assessment for Dissolution similarity as part of submission requirements.

·         Statistical support for query response.

• Other statistical analysis for content uniformity, probability of dissolution failures

Area Of Responsibility:-

• Statistical analysis of process parameter and material attributes, to identify probable route cause.
• Shelf life extrapolation for filling and query requirements.
• Inverse extrapolation for release limits identification.
• Multivariate analysis for manufacturing investigations.
• Dissolution similarity by model dependent and independent methods.
• DoE for route cause investigation and confirmation as applicable
• Process capability assessment as needed.
• Training of CFT’s on Basic statistic and stability analysis
• Statistical support for justifying specification limits
• Content uniformity assessment as per need, based on ASTM E2709/E2810

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm

Experience

Tenure: 2-5 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!

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).