About the role
- 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).
RequirementsRequired Qualifications:
- 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
Skills & Competencies:
- 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