Senior QA Executive / Senior QA Associate (Software Company – Pharma Domain)

Senior QA Executive / Senior QA Associate

Key Responsibilities

• Review and test software features for pharma regulatory compliance (

  GMP, GxP, 21 CFR Part 11

  ).
• Support complete software validation lifecycle (

  IQ/OQ/PQ documentation, validation protocols, risk assessments

  ).
• Review, prepare, and maintain

  SOPs, user manuals, validation documents

  , and other quality-related documentation.
• Work closely with pharma clients to understand quality workflows and map them to the software.
• Participate in internal, external, and client audits for software quality and compliance.
• Coordinate with development and internal QA teams to ensure high-quality, compliant, bug-free releases.
• Maintain complete traceability using

  URS → FRS → Design → Test Cases → Validation Reports

  mapping.
• Support implementation teams in client discussions related to

  pharma quality processes and compliance

  .

Skills Required

• Strong understanding of

  Pharma QA processes

  (Deviations, CAPA, Change Control, Audit Trail, Data Integrity).
• Knowledge of

  QMS, LIMS, LMS, or Document Management Systems

  .
• In-depth knowledge of regulatory guidelines (

  21 CFR Part 11, Annex 11, GAMP 5

  ).
• Experience in

  software testing, CSV (Computer System Validation), and documentation

  .
• Excellent communication skills for client coordination and audit discussions.

Experience Required

• Minimum 5 years of relevant experience

  in Pharma QA or Pharma Software QA/Validation.

Salary Range

• ₹10,00,000 to ₹16,00,000 per annum (10–16 LPA)

• (Based on experience and interview performance)