Quality Assurance - CSV

Experience- 7 To 9 Years

Designation: Executive to Deputy Manager

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.

Skills: csv,cqa,computerised system validation