HR Manager at Yo HR Consultancy
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Quality Assurance Professional - CQA (7-10 yrs)
Designation: Executive to Deputy Manager
Experience- 7 to 9 years
Must have-
Experience in CQA and CSV
Key Responsibility Areas
Regulatory & Compliance- Computerized System's Lifecycle Management
- Shall responsible to assess and initiate change control based on observation during qualification or routine observation for GxP impacting computerized systems.
- Shall identify and document the observed or occurred deviations for GxP impacting computerized systems.
- Shall thoroughly evaluate the root cause and causes assigned for proposed CAPA for GxP impacting computerized systems.
Validation Strategies- To prepare the project plan and initiate subsequent actions w.r.t. GxP computerized systems validation activities.
- Shall be responsible for preparation and review of validation/ qualification documents related to GxP impacting computerized systems as per the 21CFR part 11& EU Annex 11 & GAMP 5 requirements.
- Ensure the necessary validation documentation is completed in alignment with the CSV SOP and policies before the release of the GxP computerized systems to users.
- Shall be responsible for coordination with the vendor for implementation of the task and it's documentation for end-to-end validation of GxP impacting computerized systems.
