Experience
1 - 4 yrs
Job Location
Jalandhar, India
Vacancy
1
Designation
Formulation & Development Executive
Job Type
Not specified
Job Description
We are looking for a highly skilled and experienced Formulation and Development Executive to join our team. The ideal candidate in the pharmaceutical industry, with a strong background in designing and developing formulations for generic drug products.
Roles and Responsibility
- Design and develop formulations for generic drug products, including solid orals.
- Conduct pre-formulation and formulation studies, such as excipient compatibility and stability testing.
- Execute trial batches, scale-up, and exhibit batches according to QbD principles.
- Prepare and review Master Formula Records (MFR), Batch Manufacturing Records (BMR), and technology transfer documents.
- Coordinate with cross-functional teams, including QA, QC, Regulatory, and 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, ensuring adherence to data integrity and GMP practices in all documentation and operations.
- Support regulatory filing documentation, such as CTD modules and product dossiers.
Job Requirements
- B.Pharm / M.Pharm in 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.