Specialist

Position: Specialist / Sr. Specialist -Quality
Location: GSS, Hyderabad, India

Role Overview
The Specialist / Sr. Specialist will drive document control excellence, quality metrics governance, and continuous improvement initiatives. This role requires strong expertise in Electronic Document Management Systems (EDMS-Track wise), regulatory compliance, and the ability to analyze, report, and improve quality performance metrics across business units. The individual will play a key role in ensuring data integrity, inspection readiness, and operational efficiency, while mentoring junior associates and supporting cross-functional stakeholders.

Major Duties and Responsibilities:
Document Management System (DMS) & Compliance

1. Lead preparation, review, and lifecycle management of controlled documents (SOPs, batch records, specifications, protocols, reports) in compliance with GMP, regulatory, and internal quality standards.
2. Act as a Subject Matter Expert (SME) for Track Wise Digital or other EDMS platforms.
3. Ensure document version control, archival, retrieval, and audit readiness within the DMS.
4. Manage document workflows, approvals, periodic reviews, and obsolescence in alignment with global policies.
5. Support regulatory inspections and internal audits by ensuring accuracy, completeness, and traceability of documentation.
6. Electronic Batch records creations, development and review.
7. Hands-on experience in LMS and LIMS management systems.

Quality Metrics & Reporting

1. Develop, monitor, and report key quality metrics (e.g., Lot Acceptance rate, overdue periodic reviews, deviation trends, Change control, CAPA effectiveness, audit observations).
2. Generate periodic dashboards and performance reports for stakeholders and leadership reviews.
3. Analyze trends and identify opportunities for process optimization and risk mitigation.
4. Drive data integrity and accuracy in reporting systems.
5. Support continuous improvement initiatives using metric-driven insights.

Operational & Stakeholder Support

1. Serve as admin/functional lead for EDMS user management, training, and access control.
2. Collaborate with cross-functional teams (QA, QC, Manufacturing, Regulatory) to ensure alignment of documentation practices.
3. Provide guidance and mentorship to junior associates on documentation standards and systems usage.
4. Lead or support process improvement and digital transformation initiatives within Quality Shared Services.
5. Independently manage assigned responsibilities and ensure timely delivery of commitments.
6. Ability to lead initiatives and work independently

Project & Deadline Management

• Manage multiple deliverables simultaneously with high accuracy and attention to detail.
• Track timelines and ensure timely completion of assigned tasks.
• Proactively communicate risks, delays, or issues to stakeholders.

Team Collaboration & Oversight

• Review work completed by team members to ensure quality and compliance.
• Provide mentoring, training, and constructive feedback to junior team members.
• Support a collaborative team environment focused on continuous improvement.

Summary of Role Expectations

• Lead preparation, review, and governance of controlled documents.
• Own and drive quality metrics reporting and analysis.
• Act as SME for EDMS platforms and support system enhancements.
• Ensure compliance, inspection readiness, and continuous improvement.

Qualification and Experience:

• B.Pharm / M.Pharm / M.S. (Chemistry, Biochemistry or related field)
• 6 to 10 years of experience in pharmaceutical industry (API/Drug Product QA environments preferred)
• Strong experience in Quality Assurance and Document Management Systems
• Proven experience in quality metrics reporting and data analysis
• Hands-on expertise with Track Wise Digital or other EDMS platforms, EBR, LMS and LIMS.
• Experience in Shared Services environment preferred
• Strong understanding of GMP, regulatory requirements, and inspection readiness

Language/Communication Skills

• Ability to read, analyze, and interpret regulatory guidelines, technical documents, and business reports
• Strong writing skills for SOPs, investigation reports, metrics dashboards, and procedures
• Effective stakeholder communication and presentation skills.