Executive - FRD Orals

Roles & Responsibilities:
• Perform statistical analysis of manufacturing data to identify probable root causes and technical issues at the site
• Assess dissolution similarity as part of regulatory submission requirements
• Provide statistical support for query responses, content uniformity, and probability of dissolution failures
• Analyze process parameters and material attributes to determine potential root causes
• Conduct shelf-life extrapolation and inverse extrapolation for release limit identification
• Perform multivariate analysis for manufacturing investigations and DoE for root cause investigations
• Conduct process capability assessments as required
• Train cross-functional teams (CFTs) on basic statistics and stability analysis
• Support specification justification and content uniformity assessment based on ASTM E2709/E2810
• Collaborate with R&D, quality, and manufacturing teams to resolve technical issues and ensure compliance with internal standards

Qualification:
• M.Pharm in Pharmacy, Pharmaceutical Technology, or related discipline

Experience:
• 2–5 years of experience in formulation R&D or statistical support in pharmaceutical manufacturing, preferably with oral dosage forms

Skills:
• Strong knowledge of statistical tools and methods for process investigation and dissolution analysis
• Proficiency in DoE, multivariate analysis, and process capability assessment
• Analytical thinking, problem-solving, and attention to detail
• Good communication and coordination skills to support cross-functional teams

About the Organization:
Sun Pharmaceutical Industries Ltd. is a global pharmaceutical leader committed to innovation, quality, and patient-centric healthcare solutions. The company fosters a collaborative environment that encourages professional growth, continuous learning, and opportunities to work on complex formulation R&D projects for oral and non-oral dosage forms.