· Literature survey, articles, regulatory guidelines, patents study for new product developments
· Preformulation study of identified new product developments and data generation.
· Undertaking trial batches for old and new products as per regulatory requirements.
· Submission of samples to AD for analysis, data compilation and evaluation.
· Completion of lab book for products executed and compilation of data for newly developed products.
· Entry in register for all raw materials, excipients and coating materials, reference samples received.
· Taking trials for products which are developed earlier and have a quality issues or market complaints.
· Taking trials for change in vendors and developing new formula for existing products and monitoring stability.
· Taking trials for products which are need to be submitted to regulatory as per request.
· Preparation and submission of Product Development Reports to regulatory for old and new products as per requirement.
· Preparation and submission of Master Formula Records to regulatory for old and new products as per requirement.
· Preparation of PP drafts, license documents, raising indents for new materials and reference products
· Attend technology transfer products at manufacturing plant during execution of first-time commercial batches.
Trouble shooting at plant for commercial products.
- Must have experience in solid orals
- Candidate must be willing for a 03 years long term association agreement
Benefits:
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
