Experience: 1 to 3 years in F&D; of soft gelatin capsules
Role Purpose
Carry out laboratory development work for softgel products, including literature surveys, prototype trials, stability studies and F&D; documentation, under the guidance of the F&D; Manager / Executive.
Key Responsibilities
Conduct literature surveys on drug substances and drug products using books, references and online sources.
Support product formulation and design based on innovator characterization and the in-house development strategy.
Conduct prototype development trials and preformulation studies.
Prepare compatibility protocols and reports, BOM, MFR, development BMR/BPR, PDR drafts, and stability protocols and reports.
Charge and withdraw stability samples,
and monitor ongoing stability studies.
Support scale-up and exhibit batches in the plant.
Prepare and periodically review F&D; SOPs.
Maintain lab cleanliness, equipment upkeep, calibration and lab records according to GMP and GDP.
Preferred Candidate Profile
B.Pharm / M.Pharm in any specialization
Experience in soft gelatin capsules is mandatory.
Theoretical knowledge of GMP and documentation
Positive written and oral communication skills
Proficient in MS Office
Valuable analytical and comparison skills
Willing to work flexible schedule when trials or batches require it