ADL AGMDGM

Ahmedabad - India

Monthly Salary: Not Disclosed

Posted on: 13 days ago

Vacancies: 1 Vacancy

Job Summary

Industry: API / Pharmaceutical Manufacturing (R&D)

Key Responsibilities:

Lead development validation and transfer of analytical methods for APIs intermediates impurities and stability samples.
Ensure compliance with ICH guidelines pharmacopeial standards and global regulatory requirements.
Support regulatory filings (DMF/ANDA/CEP) and handle audit and inspection queries as SME.
Provide analytical support to process development scale-up validation and manufacturing.
Review and approve analytical documents protocols and reports; ensure data integrity compliance.
Lead and mentor analytical teams; ensure timely project delivery and resource planning.
Drive continuous improvement and adoption of advanced analytical techniques.

Qualification & Experience:

./Ph.D. in Analytical Chemistry or related field
10–18 years experience in Analytical R&D within API industry
Strong regulatory inspection and filing exposure

Industry: API / Pharmaceutical Manufacturing (R&D)Key Responsibilities:Lead development validation and transfer of analytical methods for APIs intermediates impurities and stability samples.Ensure compliance with ICH guidelines pharmacopeial standards and global regulatory requirements.Support regul...