Amneal Pharmaceuticals is a global leader in generic and specialty pharmaceuticals, committed to improving patient access to high-quality, affordable medicines. With a strong presence in Ahmedabad, we adhere to cGMP, USFDA, and other international regulatory standards, ensuring excellence in manufacturing, quality assurance, and compliance.
Join our dynamic team and contribute to innovative pharmaceutical solutions that impact lives worldwide!
Job Description – Executive Quality Assurance (APQR)
Amneal Pharmaceuticals is hiring an Executive – Quality Assurance (APQR) to ensure product quality compliance and regulatory adherence. This role involves data analysis, trend monitoring, and quality improvement initiatives in a cGMP-compliant environment.
Key Responsibilities:
✔ Data Collection & Compilation: Gather and organize manufacturing, testing, deviation, complaint, stability, and market return data for APQR.
✔ Trend Analysis & Reporting: Analyze quality trends, identify risks, and prepare Annual Product Quality Review (APQR) reports per USFDA/WHO/EU-GMP guidelines.
✔ Cross-functional Collaboration: Work with QA, QC, Production, and Regulatory teams to resolve discrepancies and ensure compliance.
✔ CAPA Implementation: Recommend Corrective & Preventive Actions (CAPA) based on APQR findings to enhance product quality.
✔ Documentation & Compliance: Maintain APQR records in alignment with cGMP, ICH Q10, and regulatory requirements.
Qualifications & Skills Required
✅ Education: M.Pharm / B.Pharm (Pharmacy graduates preferred).
✅ Experience: 1-3 years in pharmaceutical QA, APQR, or quality compliance roles (Freshers with strong academic knowledge may apply).
✅ Regulatory Knowledge: Understanding of cGMP, USFDA, EU-GMP, ICH guidelines.
✅ Analytical Skills: Ability to interpret data, identify trends, and generate reports.
✅ Attention to Detail: Ensures accuracy in documentation & compliance.
✅ Communication: Strong coordination with cross-functional teams.
Why Join Amneal Pharmaceuticals?
🔹 Global Exposure: Work with a leading USFDA-approved pharmaceutical company.
🔹 Career Growth: Opportunities in quality assurance, compliance, and regulatory affairs.
🔹 Innovative Work Culture: Collaborative environment with a focus on continuous improvement.
🔹 Competitive Salary & Benefits: Attractive compensation with industry-standard perks.
