Key Responsibilities:
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
Required 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:
Solid analytical and problem-solving skills
Positive communication and coordination abilities
Knowledge of regulatory guidelines (MHRA, EU-GMP)
Attention to detail and commitment to quality
📌 Formulation And Development Executive Chandigarh
🏢 TalentXplore
📍 Chandigarh
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