Senior Associate

3 days ago

Vizag, Andhra Pradesh, India Eisai Full time ₹ 6,00,000 - ₹ 8,00,000 per year

Job Purpose

We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations.

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.

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