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

- Robust 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.

Job Snapshot

Updated Date

02-09-2026

Job ID

JOB11036

Division

SIKKIM QA II

Location

Zhl - Sikkim|zhl-sikkim Plt., Gangtok, Sikkim, India ..+ 1

Experience

8 - 12 Years

Employee Type

P-P7-Probationer-HO Staff

📌 Assistant Manager / Deputy Manager - QA Data Integrity (Gangtok)
🏢 Zydus Group
📍 Gangtok