Validation Lead

Job Summary:

We are seeking a Validation GxP Consultant to prepare, review, and manage GxP-compliant validation documentation for regulated industries like pharmaceuticals, biotech, and medical devices. The role involves ensuring compliance with FDA, EMA, and industry standards for system validation and quality assurance.

Key Responsibilities:

Prepare and review validation documentation (URS, FRS, IQ, OQ, PQ, SOPs, etc.).

Ensure compliance with GxP, 21 CFR Part 11, Annex 11, and CSV guidelines.

Collaborate with stakeholders for validation planning and execution.

Maintain traceability matrices and risk assessments.

Support audits and regulatory inspections.

Required Skills & Qualifications:

3+ years in GxP validation and documentation.

Knowledge of CSV, 21 CFR Part 11, and regulatory requirements.

Experience with pharma, biotech, or medical device industries.

Strong technical writing and compliance documentation skills.

Familiarity with TrackWise, Veeva, or similar QMS tools (preferred).