15 Aug
|
Briskwin IT Solutions
|
Ahmedabad
15 Aug
Briskwin IT Solutions
Ahmedabad
Exp: 9+ years
Location: Hyderabad/ Mumbai/ Chennai/ Bangalore/Noida/Coimbatore/Ahmedabad/Dehradun
Np: Immediate Joiner only
Industry
Pharmaceuticals / Medical Devices / Clinical Research
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 solid 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 rese
📌 Support Lead – GxP Systems – QMS (Ahmedabad)
🏢 Briskwin IT Solutions
📍 Ahmedabad