2.0 - 5.0 years

2 - 4 Lacs

Ahmedabad

Work from Office

Job Title: F&D Executive Experience: 23 Years Department: Formulation & Development (F&D) Location: Prahladnagar, Ahmedabad Reporting To: F&D Manager / R&D Head Job Description: We are looking for a skilled and detail-oriented F&D Executive with 2–3 years of hands-on experience in pharmaceutical formulation development. The ideal candidate should possess a solid understanding of global regulatory guidelines (e.g., ICH, USFDA, EMA) and strong expertise in dissolution method development. The role involves supporting product formulation, optimization, and technology transfer activities in line with international quality and compliance standards. Key Responsibilities: Develop and optimize formulations for new and existing products across various dosage forms. Conduct pre-formulation studies, compatibility studies, and stability evaluations. Design and execute dissolution method development and validation as per international guidelines (USP, Ph. Eur., JP, etc.). Prepare and maintain technical documentation including MFRs, BMRs, development reports, and validation protocols. Ensure compliance with global regulatory requirements (ICH, USFDA, EMA, WHO) throughout development stages. Support scale-up, exhibit batch preparation, and technology transfer to manufacturing. Collaborate with cross-functional teams including QA, QC, Regulatory Affairs, and Production. Required Skills & Knowledge: In-depth knowledge of worldwide regulatory guidelines related to formulation and dissolution. Hands-on experience with analytical instruments and dissolution testing (e.g., USP Apparatus I & II). Familiarity with cGMP, GLP, and ICH Q8/Q9/Q10 guidelines. Strong technical writing, documentation, and data interpretation skills. Ability to work in a fast-paced, cross-functional environment with attention to detail.

Posted 1 month ago

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