RA Formulation
4 days ago
Job Purpose:
To lead and support formulation development activities for solid and liquid dosage forms, including nutraceuticals, ensuring regulatory compliance and robust documentation for domestic submissions.
Key Responsibilities:
Formulation Development:
Design and develop solid (tablets, capsules) and liquid (syrups, suspensions) dosage forms.
- Conduct pre-formulation studies, prototype development, and scale-up trials.
Optimize formulations for stability, bioavailability, and manufacturability.
Nutraceutical Expertise:
Develop innovative nutraceutical formulations aligned with market trends and therapeutic needs.
Evaluate functional ingredients, excipients, and delivery systems for efficacy and safety.
Regulatory Compliance:
Prepare and review technical documentation for domestic regulatory submissions (FSSAI, CDSCO, etc.).
Ensure adherence to regulatory guidelines and pharmacopeial standards.
Stability Studies:
Design and execute stability protocols as per ICH guidelines.
Analyze stability data and prepare reports for product registration and shelf-life determination.
Technology Transfer:
Support scale-up and technology transfer to manufacturing units.
Collaborate with cross-functional teams including QA, QC, RA, and Production.
Documentation & Reporting:
Maintain comprehensive records of formulation trials, batch manufacturing records, and development reports.
- Prepare product development reports and dossiers for internal and external audits.
Desired Candidate Profile:
- Education: M.Pharm in Pharmaceutics or related field
- Experience: 1-2 years in formulation development for domestic market
Skills:
Hands-on experience in solid and liquid dosage forms
- Knowledge of nutraceuticals and functional ingredients
- Familiarity with domestic regulatory frameworks
- Proficiency in stability study design and documentation
- Strong analytical and problem-solving skills
Preferred candidate profile - Male
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