Document Management Systems Specialist

India, Hyderabad

Document Management Systems Specialist

Location: Hyderabad, India

Job Description:

As a Document Management Systems Specialist, you will manage document lifecycle activities in the electronic Document Management System (eDMS) with accuracy and compliance. This role supports global and site users, ensuring a controlled, reliable, and inspection-ready document environment. You will act as a coordinator for eDMS application activities, provide user support, and contribute to continuous improvement of document management processes across Lonza’s global network.

Key Responsibilities

• eDMS Coordination: Manage ownership of documents (single/mass changes), properties, distribution lists, secure groups, and delegation settings.

• User Support: Act as point of contact for resolution of global/local DMS user requests (via ticketing and email).

• Document Lifecycle Management: Oversee end-to-end document lifecycle (draft, review, approval, effective, archive) ensuring timely processing within workflows.

• Metadata & Data Quality: Assign and maintain accurate document metadata (type, owner, effective date).

• System Administration: Support day-to-day eDMS operations including routing, status updates, and user queries. Maintain templates, workflows, and system configurations.

• Compliance: Ensure adherence to GxP requirements and Good Documentation Practices (GDP/ALCOA+).

• Controlled Documents: Support management of controlled copies, including tracking and reconciliation.

• Reporting & Monitoring: Generate reports (document status, overdue reviews, cycle times) and highlight risks or delays.

• Continuous Improvement: Identify opportunities to simplify and improve document management processes; support system enhancements.

• Global Collaboration: Work closely with global stakeholders across sites and functions, ensuring clear communication across time zones.

• Approval Support: Review and approve global documentation to ensure compliance with administrative rules (formatting, references, layout, properties).

• System Testing: Support technical issue resolution, OQ/PQ testing, and implementation of DMS improvements.

• Training Coordination: Assign and track completion of eDMS-specific training activities in Cornerstone.

• Other Duties: Perform additional tasks as required to support global DMS operations.

Organization Size

• Direct/Indirect Reports: None

• Financial Responsibility: N/A

Key Metrics

• Relevant KPIs defined in Lonza’s LBMS Performance Cockpit and GROUP-2312 Quality Metrics.

Key Stakeholders

• Site/Regional QMS Representatives

• Global Quality

• DMS Users

Required Skills & Competencies

• Self-starter and solution-driven mindset.

• Team player with enthusiasm for continuous improvement of QMS.

• Strong PC and software skills, especially Microsoft Office; Power BI and electronic systems experience a plus.

• Understanding of process mapping and performance analysis desirable.

• Excellent communication skills with ability to interact in an international environment.

• Fluent spoken and written English; German desirable.

Qualifications

• Education: Bachelor’s degree in chemistry, Biochemistry, or Pharmacy.

• Experience:

  • Experience with Quality System Management in a GMP-regulated environment.

  • Background in (Bio)pharmaceuticals or similar highly regulated industry.

About Lonza

At Lonza, document management is critical to ensuring compliance, reliability, and inspection readiness across our global operations. Our Document Management Systems Specialists play a vital role in maintaining controlled documentation, supporting global users, and driving continuous improvement. Guided by our values—Collaboration, Accountability, Excellence, Passion, and Integrity—we foster innovation and compliance excellence. By joining Lonza, you will help shape the future of document management and contribute to the medicines of tomorrow.