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01/03 Yo Hr Consultancy
HR Manager at Yo HR Consultancy

Views:134 Applications:6 Rec. Actions:Recruiter Actions:0

Quality Assurance Professional - CQA (7-10 yrs)

Mumbai Job Code: 34923

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.

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