Executive / Sr. Executive - QA (Market Compliance)

Job description

Roles and Responsibilities • Ensure compliance with US FDA regulations, including 21 CFR Part 211 , ICH Q10, through documentation review, audits, and inspections. • Develop and maintain quality systems, procedures, and protocols for regulatory compliance. • Collaborate with cross-functional teams to implement corrective actions and preventive measures (CAPA). • Conduct risk assessments to identify potential hazards in marketed products and develop mitigation strategies. Desired Candidate Profile • 6-10 years of experience in Quality Assurance or related field with expertise in Market Compliance (US FDA). • Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. • Strong understanding of 21 CFR Part 820 regulations and familiarity with USFDA guidelines.