Job Title:
Quality Assurance Validator
About the Role:
The Quality Assurance Validator is a key member of our team responsible for ensuring quality oversight in Commissioning, Qualification and Validation activities. This role involves providing QA oversight to CQV activities associated with site transition from project phase through sustaining phase. Key responsibilities include ensuring quality oversight of qualification/validation activities, reviewing validation documentation and data, conducting investigations, and managing the QA Validations team.
Responsibilities:
1. Ensure quality oversight of qualification/validation activities related to facilities, utilities, equipment, computerized systems,
cleaning processes,
m manufacturing processes,
estorage areas,
controlled temperature units (CTUs),and shipping processes.
2. Review all validation documents including plans,URSs.quality risk assessments.
protocols.
&
data against applicable acceptance criteria under cGMP guidelines.
3. Conduct thorough root cause analysis using Ishikawa diagrams or FMEA tools where necessary.
, Provide support during client audits and regulatory inspections –e.g., FDA/EU regulated environment.,SAP/compliance-driven industry standards like GAMP/Iso-9001/.proof iwsr*aE,g.F '