Formulation and Development Executive

•  Design and develop formulations for generic drug products (solid orals)
  
•  Conduct pre -formulation and formulation studies, including excipient compatibility and stability testing.
  
•  Experience in technology transfer
  
•  Execute trial batches, scale -up, and exhibit batches as per QbD principles.
  
•  Prepare and review Master Formula Records (MFR), Batch Manufacturing
  
•  Records (BMR), and technology transfer documents.
  
•  Coordinate with cross -functional teams (QA, QC, Regulatory, Production) during development and tech transfer.
  
•  Participate in process validation and exhibit batch manufacturing.
  
•  Handle troubleshooting during scale -up and validation at the plant level.
  
•  Prepare product development reports and regulatory documentation as per MHRA/ICH/WHO guidelines.
  
•  Ensure adherence to data integrity and GMP practices in all documentation and operations.
  
•  Support regulatory filing documentation (e.g., CTD modules, product dossiers).
  

Requirements

•  B.Pharm / M.Pharm – Pharmaceutics / Industrial Pharmacy
  
•  Sound knowledge of MHRA, ICH, QbD, and cGMP regulations
  
•  Proficient in documenting and reviewing technical reports and protocols
  

•  Strong analytical and problem -solving skills
  
•  Good communication and coordination abilities
  
•  Knowledge of regulatory guidelines (MHRA, EU -GMP)
  
•  Attention to detail and commitment to quality