Generic Pharmaceuticals

Prepares and maintains regulatory submissions to FDA, EMA, MHRA, PMDA, and CDSCO.

Leads quality assurance programs, supplier audits, and deviation/CAPA systems across GMP sites.

Optimizes API and formulation processes via QbD, DoE, and scale-up activities.

Oversees batch manufacturing operations, BMR review, and shop-floor GMP compliance.