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Zentiva

Executive I - Quality Assurance

1w

Zentiva

Ankleshwar, IN · Full-time · INR 500,000 – INR 900,000

About this role

The Executive I - Quality Assurance role focuses on maintaining high standards in pharmaceutical manufacturing through quality management and continuous improvement. Key areas include line clearance, shop floor compliance, and in-process checks. This position ensures adherence to cGMP, GDP, and quality systems in a dynamic pharma environment.

Day-to-day duties involve handling e-tools like SAP Hana, LIMS, eDMS, and TrackWise for documentation and investigations. Professionals will review batch manufacturing and packing records, assist in complaint investigations, and prepare Annual Product Quality Reviews. Coordination across functions supports validation, change control, and deviation management.

Working in a cross-functional team, the role emphasizes compliance with local FDA and MHRA regulations via gap analysis and execution of compliance plans. Collaboration ensures validated status of equipment, processes, and cleaning. Attention to detail drives data integrity and SOP compliance.

Growth opportunities arise through involvement in cGMP training, protocol reviews, and CAPA implementation. The position builds expertise in regulatory expectations and quality assurance systems. Continuous improvement initiatives enhance skills in documentation control and process validations.

Requirements

  • 1–5 years of relevant experience in Pharma Quality Assurance / Documentation
  • Strong knowledge of cGMP, GDP, and Quality Systems
  • Hands-on experience with batch documentation and document control systems
  • Good understanding of APQR preparation and regulatory expectations
  • Strong analytical, organizational, and coordination skills
  • Effective communication and cross-functional collaboration abilities
  • Attention to detail and commitment to data integrity

Responsibilities

  • Perform line clearance and ensure shop floor compliance
  • Carry out in-process checks and calibration of IPQC instruments
  • Handle e-tools including SAP Hana, LIMS, eDMS, and TrackWise
  • Assist in complaint investigations, qualifications, validations, change controls, and deviations
  • Prepare and review Annual Product Quality Reviews (APQR)
  • Review Batch Manufacturing and Packing Records
  • Coordinate cGMP training activities
  • Conduct gap analysis and execute compliance plans for regulatory adherence