Assistant Manager / Deputy Manager - QA Data Integrity

Company Name: Zydus Healthcare Limited
Industry: Pharmaceuticals
Website: https://www.zyduslife.com/zyduslife/
Location: Sikkim Unit I & Unit II
Position: Assistant Manager / Deputy Manager
Department: Quality Assurance (QA)
Role: Data Integrity
Qualification: B.Pharm / M.Pharm / M.Sc.
Experience: 8 to 12 Years

Job Summary

Zydus Healthcare Limited is seeking an experienced professional for the position of Assistant Manager / Deputy Manager - Data Integrity at its Sikkim Location. The incumbent will be responsible for strengthening and maintaining the Data Integrity across the site, ensuring compliance with global regulatory requirements, fostering a culture of compliance, and supporting inspection readiness.

Key Responsibilities

• Lead and manage site-wide Data Integrity (DI) initiatives in line with regulatory expectations and company policies.
• Ensure compliance with ALCOA+ principles and Data Integrity requirements across GMP functions.
• Conduct periodic Data Integrity audits and assessments of Manufacturing, Quality Control, Quality Assurance, Engineering, Warehouse, and computerized systems.
• Review and monitor audit trails of GMP computerized systems and ensure timely closure of observations.
• Drive Data Integrity gap assessments and implementation of remediation plans.
• Review and approve Data Integrity risk assessments, impact assessments, and mitigation plans.
• Investigate Data Integrity-related deviations, incidents, discrepancies, and support CAPA implementation.
• Support qualification and validation of computerized systems from a Data Integrity compliance perspective.
• Review user access management, system controls, electronic records, and electronic signatures for GMP systems.
• Conduct Data Integrity training and awareness programs for cross-functional teams.
• Support internal audits, self-inspections, mock audits, and regulatory inspections.
• Ensure compliance with Data Governance procedures and company quality systems.
• Monitor Data Integrity metrics and prepare periodic management review reports.
• Coordinate with Corporate Quality and Site Leadership for continuous improvement initiatives.

Required Skills & Competencies

• Strong knowledge of Data Integrity principles including ALCOA+, 21 CFR Part 11, Annex 11, and GMP requirements.
• Experience in Data Integrity audits, investigations, risk assessments, and CAPA management.
• Understanding of computerized systems validation (CSV) and audit trail review requirements.
• Familiarity with regulatory expectations from USFDA, MHRA, WHO, EU GMP, and PIC/S guidelines.
• Strong knowledge of Quality Management Systems, Change Control, Deviations, OOS, and CAPA processes.
• Excellent analytical, documentation, and technical writing skills.
• Strong leadership, communication, and stakeholder management capabilities.
• Proficiency in MS Office and electronic Quality Management Systems.

Preferred Experience

• Experience in pharmaceutical manufacturing facilities regulated by USFDA, MHRA, EU, or WHO authorities.
• Exposure to TrackWise, LMS, DMS, ERP, LIMS, Empower, or similar GMP systems.
• Experience in leading regulatory inspections and Data Integrity improvement projects.
• Certification or formal training in Data Integrity, Quality Systems, or Regulatory Compliance will be an added advantage.