Senior Associate / Specialist - IT Quality Assurance

Job Purpose

IT QA professional

Roles & Key Responsibilities

• Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.).
• Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of protocols and reports.
• Perform incident management, troubleshooting, root cause analysis, and CAPA implementation for IT systems.
• Administer TrackWise system including workflow updates, process enhancements, validation, and troubleshooting.
• Ensure vendor/service provider qualification, periodic assessment, and risk-based requalification of GxP software vendors.
• Drive compliance in Change Control, Deviation, and CAPA processes within the TrackWise QMS.
• Conduct internal audits to verify compliance with cGMP and data integrity standards.
• Coordinate with RA for regulatory submissions and support CMO quality management activities.

Key Skills Required

• Strong expertise in

  IT Quality Assurance

  within regulated pharmaceutical environments.
• Hands-on experience in

  TrackWise administration, validation, and QMS integration

  .
• Knowledge of

  global regulatory standards

  (USFDA, EMA, PMDA, WHO, CDSCO).
• Experience in

  software validation

  (DQ, IQ, OQ, PQ) and data integrity compliance.
• Incident management and troubleshooting skills for SAP, AmpleLogic, LIMS, eLMS.
• Strong understanding of

  Change Control, Deviation, CAPA, and Quality Agreements

  .
• Ability to perform

  vendor/service provider qualification and audits

  .
• Good documentation practices, SOP review, and regulatory audit preparedness.
• Coordination and cross-functional collaboration skills.

Desired Candidate Profile

• Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc / B.Tech (preferred in IT, Life Sciences, Biotechnology, Pharmacy).
• Experience: 510 years (Pharmaceutical industry exposure with IT QA is a must).
• Strong analytical and problem-solving skills with attention to detail.
• Prior experience with software like TrackWise, SAP, AmpleLogic, LIMS, eLMS is mandatory.