Role & responsibilities

Support Lead GxP Systems – QMS — Job Description

SubTSR – Support Lead - QMS

Position Title

Support Lead – GxP Systems - QMS

Experience

6–8 Years

Industry

Pharmaceuticals / Medical Devices / Clinical Research

Location

India / Hybrid / Remote

Job Summary

We are seeking a skilled Support Lead with experience supporting regulated GxP QMS systems within pharmaceutical, medical device, and clinical research environments.

The candidate will be responsible for providing application and operational support for critical regulated platforms including Quality Management Systems (QMS), and related GxP applications.

The ideal candidate should possess strong troubleshooting skills, understanding of regulated environments, incident management expertise, and the ability to support business-critical applications while maintaining compliance and system availability.

Key Responsibilities

- 3-4 years of experience in Salesforce applications and functional knowledge.
• Provide Level 2 / Level 3 support for regulated GxP applications.
• Support and maintain systems such as QMS platforms, laboratory applications, manufacturing systems, and quality systems.
• Monitor application health, system performance, and service availability.
• Investigate and resolve application incidents, defects, and user-reported issues.
• Perform root cause analysis and implement corrective actions.
• Manage service requests, tickets, and issue tracking through ITSM tools.
• Support system upgrades, patches, releases, and configuration changes.
• Coordinate with vendors and internal technical teams for issue resolution.
• Ensure compliance with GxP, 21 CFR Part 11, Data Integrity requirements, and Change Management procedures.
• Support audit and inspection readiness activities.
• Prepare and maintain support documentation, SOPs, and knowledge articles.
• Participate in on-call or production support activities when required.

Required Skills & Qualifications

- 6–7 years of experience supporting GxP systems in pharmaceutical, medical device, or clinical research environments.
• Hands-on experience with one or more systems including QMS applications, and laboratory systems.
• Strong understanding of GxP compliance, 21 CFR Part 11, Data Integrity principles,



Incident and Change Management.
• Experience with ticketing systems, ServiceNow, JIRA, and ITSM processes.
• Strong troubleshooting and root cause analysis skills.
• Experience supporting production systems in regulated environments.
• Familiarity with database queries, application logs, and system configurations.
• Good understanding of SDLC and validation concepts.

Preferred Qualifications

- Exposure to pharmaceutical laboratory workflows.
• Experience supporting global users and cross-functional teams.
• Knowledge of validation documentation and change control processes.
• ITIL certification preferred.

Soft Skills

- Strong communication and user support skills
• Detail-oriented and compliance-focused
• Ability to work under pressure and tight timelines
• Strong analytical and problem-solving abilities
• Good coordination and stakeholder management skills

Support Engineer – GxP Systems – QMS — Job Description

SubTSR – Support Engineer - QMS

Position Title

Support Engineer – GxP Systems - QMS

Experience

4–5 Years

Industry

Pharmaceuticals / Medical Devices / Clinical Research

Location

India / Hybrid / Remote

Job Summary

We are seeking a skilled Support Engineer with experience supporting regulated GxP systems within pharmaceutical, medical device, and clinical research environments.

The candidate will be responsible for providing application and operational support for critical regulated platforms including Quality Management Systems (QMS), and related GxP applications.

The ideal candidate should possess strong troubleshooting skills, understanding of regulated environments, incident management expertise, and the ability to support business-critical applications while maintaining compliance and system availability.

Key Responsibilities

- 2-3 years of experience in Salesforce applications, knowledge SF configuration,



security, user access management, SF product and patches and updates
• Provide Level 2 / Level 3 support for regulated GxP applications.
• Support and maintain systems such as QMS platforms, laboratory applications, manufacturing systems, and quality systems.
• Monitor application health, system performance, and service availability.
• Investigate and resolve application incidents, defects, and user-reported issues.
• Perform root cause analysis and implement corrective actions.
• Manage service requests, tickets, and issue tracking through ITSM tools.
• Support system upgrades, patches, releases, and configuration changes.
• Coordinate with vendors and internal technical teams for issue resolution.
• Support audit and inspection readiness activities.
• Prepare and maintain support documentation, SOPs, and knowledge articles.
• Participate in on-call or production support activities when required.

Required Skills & Qualifications

- 3–4 years of experience supporting GxP systems in pharmaceutical, medical device, or clinical research environments.
• Hands-on experience with one or more systems including QMS applications, and laboratory systems.
• Strong understanding of GxP compliance, 21 CFR Part 11, Data Integrity principles, Incident and Change Management.
• Experience with ticketing systems, ServiceNow, JIRA, and ITSM processes.
• Strong troubleshooting and root cause analysis skills.
• Experience supporting production systems in regulated environments.
• Familiarity with database queries, application logs, and system configurations.
• Good understanding of SDLC and validation concepts.

Preferred Qualifications

- Exposure to pharmaceutical laboratory workflows.
• Experience supporting global users and cross-functional teams.
• Knowledge of validation documentation and change control processes.
• ITIL certification preferred.

Soft Skills

- Solid communication and user support skills
• Detail-oriented and compliance-focused
• Ability to work under pressure and tight timelines
• Strong analytical and problem-solving abilities
• Good coordination and stakeholder management skills

Preferred candidate profile

📌 salesforce exchange + dms (Pune)
🏢 Hexaware Technologies
📍 Pune