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Executive / Sr. Executive - QA (Market Compliance)

Aurobindo Pharma · Hyderabad, Telangana, India - Jadcherla, Telangana, India

2–8 yrs experiencefull_timePosted 2w ago
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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.