Quality and Validation Specialist

Thompsons HR Consulting Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Thompsons HR Consulting Pvt Ltd in Hyderabad is seeking a Validation Specialist with extensive pharmaceutical or FMCG experience to lead and execute end-to-end validation activities.

The role requires IQ/OQ/PQ design and execution, strong documentation skills, and the ability to develop standards, SOPs, and validation master plans, while ensuring compliance with cGMP, FDA, WHO, ISO and GAMP 5.

Qualifications

• Experience designing and executing validation protocols (IQ/OQ/PQ).
• Proven experience writing validation reports and core validation documentation.
• Experience developing and maintaining validation standards, SOPs, and validation master plans.
• Demonstrated work under cGMP, FDA, WHO, ISO, and GAMP 5 requirements in regulated environments.
• Proven track record leading and managing site-level or multi-site validation projects (planning, execution, documentation).

Responsibilities

• Plan validation projects and timelines; coordinate with cross-functional teams.
• Execute validation protocols, collect data, and ensure quality compliance.
• Prepare and maintain validation reports and master documentation.
• Ensure compliance with regulatory standards and site-specific quality systems.

Skills

Validation

IQ/OQ/PQ

Pharma/FMCG

Documentation

cGMP/FDA/WHO

Project leadership

Job description

• Validation specialist with 10 15 years experience in pharmaceutical and/or FMCG environments
• Direct experience designing and executing validation protocols (IQ/OQ/PQ)
• Proven experience writing validation reports and core validation documentation
• Experience developing and maintaining validation standards, SOPs, and validation master plans
• Demonstrated work under cGMP, FDA, WHO, ISO, and GAMP 5 requirements in regulated environments
• Proven track record leading and managing site-level or multi-site validation projects (planning, execution, documentation)