Manager - IT QA & CSV

Key Responsibilities:

Computerized System Validation (CSV):

• Provide validation expertise on

  GxP-compliant applications

  in the drug safety space.
• Serve as

  SME in CSV practices

  , ensuring best practices are consistently followed.
• Review and approve key CSV deliverables: Requirement Specifications, Validation Plans, Test Plans, Traceability Matrix, Test Summary Reports, Qualification Scripts, and Validation Summary Reports.
• Lead validation and

  UAT activities

  for client product implementation projects.
• Guide the testing team in

  manual and automated testing

  , OQ, PQ, IQ, and other SDLC artifacts.
• Support internal QA team during

  client, internal, and regulatory audits

  .
• Apply

  risk-based system validation approaches

  and the V-Model methodology.
• Collaborate with SMEs for

  requirements analysis, risk assessment, profiling, and mitigation

  .
• Oversee

  Change Control, Deviation Handling, Document Management, and CAPA

  procedures.

Quality Assurance Operations:

• Maintain strong knowledge of

  GxP, GDP, GTP, QA best practices

  and regulatory compliance (FDA, EMA, MHRA, PMDA).
• Ensure adherence to

  21 CFR Part 11 and EU Annex 11

  guidelines.
• Anchor updates to

  QMS

  and participate in

  continual improvement programs

  .
• Coordinate revision, review, and approval of

  IT SOPs and GxP documents

  .
• Train and mentor resources on

  QA practices and CSV

  .

Team and Stakeholder Management:

• Manage, mentor, and coach a team of QA professionals, including onboarding, career development, and performance evaluation.
• Engage with clients to build confidence and maintain relationships.
• Conduct

  capacity planning and resource forecasting

  .
• Ensure effective management of

  multiple projects

  while maintaining the balance between quality and productivity.
• Oversee cross-training of staff and promote

  teamwork and motivation

  .