Associate III - Product Support

3 - 5 Years
2 Openings
Bangalore

Position Overview:

We are seeking an experienced IT
Validation Consultant to lead and support the validation of LIMS used
in bioanalytical and clinical research. The ideal candidate will have
hands-on experience with Watson LIMS in a regulated GxP environment,
ensuring systems are compliant with FDA, EMA, MHRA, and other applicable
regulatory requirements.

Key Responsibilities:

• Plan, author, and execute validation activities for Watson LIMS
  and SampleManager including IQ, OQ, PQ protocols, and 21 CFR
  Part 11 compliance assessments.
• Develop and review validation documentation: Validation
  Plans, URS, FRS, Risk Assessments, Traceability Matrix, Validation Summary
  Reports, etc.
• Ensure Watson LIMS and associated modules are validated in
  compliance with GAMP 5, GxP, and data integrity principles.
• Collaborate with QA, IT, Laboratory, and Clinical teams to
  gather requirements, assess risks, and ensure system suitability.
• Participate in change control activities, periodic
  reviews, and system upgrades from a validation perspective.
• Support audits and inspections by regulatory authorities or
  sponsors, including preparation of validation documentation and addressing
  observations.
• Review and verify data integrity and audit trail functionality
  for compliance with applicable regulatory standards.
• Provide guidance and training to stakeholders on validation
  best practices and Watson LIMS compliance.

Required Qualifications:

• Bachelor s or Master s degree in Life Sciences, Computer
  Science, IT, or related field.
• Minimum 3+ years of experience in IT Validation or
  Computer System Validation (CSV) in a regulated life sciences
  environment.
• Hands-on experience validating Watson LIMS in bioanalytical or clinical settings.
• Strong understanding of FDA 21 CFR Part 11, EU Annex 11,
  GAMP 5, ALCOA+ principles, and ICH E6 (R2).
• Experience with bioanalytical workflows, clinical sample
  management, and LIMS data structures.
• Familiarity with audit trail review, electronic signature
  validation, and data lifecycle management.
• Strong technical documentation and project management skills.

Preferred Qualifications:

• Prior experience in CROs, clinical research
  organizations, or pharmaceutical/biotech companies.
• Knowledge of laboratory processes such as PK, TK, and
  biomarker studies.
• Experience with integration of Watson LIMS with other lab or
  enterprise systems (e.g., CDS, ELN, CTMS).
• Validation or QA certifications a plus.

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