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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.
Experience
8 - 12 Years
Employment type
P-P7-Probationer-HO Staff
Work arrangement
No
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