Specialist, Process Optimization - GMP Analyst
IND - Telangana - Hyderabad (HITEC City), India
INR 885K-1475K (estimate) Mid-level Full Time
Tasks
- Collaborate with Quality IT Product teams
- Contribute to SOP development
- Create validation documentation
- Define validation scope and resource needs
- Ensure compliance with SDLC SOP
- Execute testing protocols
- Maintain system documentation and configuration profiles
- Manage change control processes
- Own GMP SDLC deliverables
- Plan product release cycles
- Support validation cycles
- Sustain IT system validation packages
Perks/Benefits
Skills/Tech-stack
Agile | Asset Management | Atlassian | Automated compliance | Automated compliance tools | CSA | CSV | Change Control | Compliance tools | Confluence | Development Life Cycle | Digital SDLC | Digital SDLC Platforms | EMA | FDA | GMP Compliance | GMP validation | GxP | ICH | IT supplier management | Jira | Manufacturing intelligence | Product Management | Regulatory Compliance | Risk-based | Risk-based validation | SDIRA | SOP Development | SOP compliance | Software Development Life Cycle | Software development | Supplier management | System Documentation | Validation Documentation
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