Job Description

Roles and Responsibilities Conduct analytical testing, stability studies, and method validation according to GLP guidelines. Ensure compliance with GMP regulations through process validation, equipment qualification, vendor qualification, change control, CAPA implementation, deviation management, SOP adherence, and OOS/OOT investigation. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Develop and maintain documentation for laboratory procedures, protocols, reports, and records. Participate in audits (internal & external) by providing necessary documents and supporting the team during audit queries. Desired Candidate Profile 7-12 years of experience in Analytical Quality Assurance or related field. Bachelor's degree in Chemistry (B.Sc). Master's degree in Science (MS/M.Sc) or equivalent in Chemistry. Strong understanding of QMS principles and regulations such as FDA cGMP/GLP/GMP requirements.