Position: Specialist / Sr. Specialist – Quality Systems

• GSS, Hyderabad, India
  Reporting To: Manager – Quality (GSS)

Role Overview
The Specialist / Sr. Specialist will drive electronic quality systems management, implementation, and continuous improvement initiatives. This role requires strong expertise in Electronic Document Management Systems (DMS), Electronic Quality Management Systems (QMS), Learning Management System (LMS) and regulatory compliance. The individual will play a key role in ensuring data integrity, inspection readiness, and operational efficiency of electronic quality systems.

Major Duties and Responsibilities:

Quality Systems & Compliance

1. Participates in authoring, executing, and approving computer system validation and data migration plans/protocols
2. Lead preparation, review, and approval of controlled documents (SOPs, specifications, protocols, reports) in compliance with GMP, regulatory, and internal quality standards.
3. Act as a Subject Matter Expert (SME) for DMS, QMS, and LMS platforms.
4. Perform administrator activities and serve as super user in DMS, QMS, and LMS platforms
5. Manage document workflows, approvals, periodic reviews, and obsolescence in alignment with global policies.
6. Participate in change management and completion of deliverables for electronic quality systems upgrades, enhancements, and implementations
7. Manage deployment and revision of training related to global quality documents and electronic quality systems in LMS
8. Helps manage global quality training curriculum within LMS
9. Serves as quality point of contact for periodic reviews and user access reviews of global quality systems

Operational & Stakeholder Support

1. Work with sites and cross-functional teams to help prepare and review master data for migration into quality systems
2. Serve as admin/functional lead for user management, training, and access control for DMS, QMS, and LMS.
3. Provide end-user support for help requests and generate system reports as needed
4. Collaborate with cross-functional teams (QA, QC, Manufacturing, Regulatory, IT) to ensure alignment of practices withing governed electronic systems
5. Provide guidance to sites and end-users on documentation standards and systems usage.
6. Lead or support process improvement and digital transformation initiatives for DMS, QMS, and LMS.
7. Independently manage assigned responsibilities and ensure timely delivery of commitments.
8. 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.
• Help manage project plans and develop implementation timelines
• Proactively communicate risks, delays, or issues to stakeholders.

Team Collaboration

• Review work completed/executed by others to ensure quality and compliance.
• Provide training as needed to other individuals/departments on electronic systems
• Support a collaborative team environment focused on continuous improvement.

Summary of Role Expectations

• Act as global SME for DMS, QMS, and LMS platforms
• Support quality system maintenance, upgrade, enhancement, and implementation projects.
• Ensure compliance, inspection readiness, and continuous improvement.

Qualification and Experience:

• B.Pharm / M.Pharm / M.S. (Chemistry, Biochemistry or related field)
• 7 to 10 years of experience in pharmaceutical industry (API/Drug Product QA environments preferred)
• Strong experience in Quality Assurance
• Previously authored, executed, or approved computer system validation or data migration protocols
• Experience preparing Master Data for migration into electronic systems
• Participated in implementation of new electronic quality systems
• Experience as super-user/Admin in electronic quality systems (DMS, QMS, or LMS)
• Experience with TrackWise Digital preferred
• Strong understanding of GMP, regulatory requirements, and inspection readiness

Language/Communication Skills

• Proficiency in English language
• Ability to read, analyze, and interpret regulatory guidelines, technical documents, and business reports
• Strong writing skills for SOPs, protocols, reports, and work instructions
• Effective stakeholder communication and presentation skills.