Executive/ Sr. Executive - Quality Assurance - APQR - Injectable Site

Role & responsibilities

• APQR Preparation & Management:
• Collect, compile, and analyze data from various departments (Production, QC, QA, Warehouse, etc.) for APQR.
• Ensure timely preparation and completion of APQRs for all marketed products.
• Review trends in product quality, deviations, complaints, OOS/OOT results, and change controls.
• Compliance & Documentation:
• Ensure APQRs are prepared in accordance with GMP guidelines (e.g., USFDA, & EU).
• Maintain accurate and complete documentation of APQRs and related records.
• 
  Coordinate with regulatory affairs for submission of annual reports when required.
• Cross-Functional Coordination:
• Liaise with Production, QC, QA, and other departments to gather necessary data.
• Facilitate meetings to discuss APQR findings and recommend corrective/preventive actions.
• Continuous Improvement:
• Identify trends and areas for improvement based on APQR findings.
• Support implementation of CAPAs and monitor their effectiveness.
• Audit & Inspection Support:
• Provide APQRs during internal and external audits.
• Address audit observations related to APQRs and ensure timely closure.

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Qualifications & Experience:

• Masters degree in Pharmacy, Chemistry, or related field.
• Minimum 57 years of experience in pharmaceutical quality assurance or documentation.
• Strong understanding of GMP, regulatory guidelines, and quality systems.

Skills Required:

• Excellent analytical and documentation skills.
• Proficiency in MS Excel, Word, and data management systems.
• Strong communication and coordination abilities.
• Attention to detail and ability to meet deadlines.