A leading firm in validation services in Hyderabad seeks a Validation Specialist to prepare and execute validation protocols, handle process validations, and ensure compliance with GMP and regulatory guidelines. The role involves collaboration with various departments and requires a minimum of 2 years of relevant experience. Candidates with knowledge of internal audits and regulatory inspections will be preferred.
Qualifications
Minimum 2 years of experience in relevant sector.
Familiarity with GMP and regulatory guidelines is required.
Responsibilities
Prepare, review, and execute validation protocols and reports.
Handle process validation and equipment qualification.
Coordinate with Production, QC, Engineering, and other departments.
Job description
Prepare, review, and execute validation protocols and reports (IQ/OQ/PQ).
Handle process validation, cleaning validation, and equipment qualification.
Support utility validation (HVAC, water systems, compressed air, etc.).
Ensure validation activities comply with GMP and regulatory guidelines.
Review validation data and ensure proper documentation and traceability.
Coordinate with Production, QC, Engineering, and other departments.
Participate in risk assessments and validation planning.
Handle deviations, change controls, and CAPA related to validation.
Maintain validation master plan (VMP) and related documents.
Support internal audits and regulatory inspections (USFDA, WHO, EU GMP).