Specialist, Process Optimization - GMP Analyst
IND - Telangana - Hyderabad (HITEC City), India
INR 1100K-1487K (estimate) Mid-level Full Time
Tasks
- Collaborate with quality IT product teams for compliance
- Contribute to SOP development and lifecycle sustainment
- Define validation scope and resource needs
- Develop testing protocols
- Execute validation documentation
- Maintain system documentation and configuration profiles
- Own GMP SDLC deliverables
- Plan product releases
- Support validation cycles and change control
Perks/Benefits
Skills/Tech-stack
Agile SDLC | Asset Management | Atlassian Confluence | Automated compliance | Automated compliance tools | CSA Methodology | CSV/CSA | Compliance tools | Computer system | Computer system validation | Development Life Cycle | Digital SDLC | EMA | FDA | GMP Compliance | GMP validation | GxP | ICH | IT supplier management | JIRA tool | Jira | Manufacturing intelligence | Product Management | Regulatory Compliance | Risk-based | Risk-based validation | SDIRA | SOP compliance | SOP documentation | Software Development Life Cycle | Software development | Supplier management | System design | System validation
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