Quality Assurance Executive

Role & responsibilities

• Perform daily IPQA activities and line clearance in the manufacturing facility.
• Conduct training for IPQA and production personnel regarding IPQA activities.
• Review and update artwork/shade cards as per proposed Change Control Note (CCN) details.
• Oversee language translation processes for documents such as quotations, PR, PO, and final artwork.
• Monitor plant critical areas for GMP compliance.
• Prepare and review GMP documents, including SOPs, protocols, and other relevant records.
• Review executed batch manufacturing/packing records, COA, and analytical data.
• Manage control sample handling and review stability sample management procedures for compliance.
• Participate in process validation and cleaning validation activities.
• Oversee non-conformance handling and ensure compliance in consultation with department heads.
• Ensure compliance with all QA and plant procedures.
• Review key documents such as Master Batch Manufacturing Records (BMR/BPR), Master Formula Cards (MFC), QC Specifications,Stability Study Reports, and Annual Product Quality Review (APQR).
• Support internal and external audits and ensure compliance with audit observations.
• Ensure fulfillment of all regulatory and market-specific requirements related to products.
• Ensure compliance with GMP regulations as per ISO, WHO, and CMDCAS standards.

Preferred candidate profile

• Bachelor's or Masters degree in Pharmacy/Science or a related field.
• Minimum of 3-5 years of experience in IPQA activities within the injectable pharmaceutical industry.
• Strong knowledge of GMP, ISO standards.
• Experience in handling regulatory audits, deviations, CAPA, and change control procedures.
• Proficiency in documentation and compliance procedures related to pharmaceutical manufacturing.
• Excellent communication, analytical, and problem-solving skills.