Required skills
- FDA Compliance
- GMP
- cGMP
- Pharmaceutical Industry
- Inspection Readiness
- Validation
- Qualification
- Computer System Validation (CSV)
- Data Integrity
- Engineering
- CAPA Management
- Project Management
Languages: French
Job description
We are looking for a Senior FDA Inspection Readiness Consultant with at least 10 years of experience in the pharmaceutical industry and proven expertise in GMP/cGMP regulatory compliance to prepare for an upcoming FDA inspection.
Project overview
As part of the preparation for an FDA inspection scheduled for April/May 2027, we are looking for a Senior FDA Inspection Readiness Consultant with a minimum of 10 years of experience in the pharmaceutical industry, with proven expertise in GMP/cGMP regulatory compliance.
A significant experience in the pharmaceutical sector as well as concrete participation in the preparation and support of FDA inspections at pharmaceutical sites are imperative.
The consultant will be involved in a strategic FDA inspection readiness program, covering the areas of Validation, Qualification, Computer System Validation (CSV), Data Integrity, and Engineering.
The objective is to ensure the site's level of readiness, identify non-compliance risks, and coordinate the necessary actions prior to the inspection.
Main Missions
Environment
- Lead and coordinate FDA inspection readiness activities.
- Develop, maintain, and monitor regulatory compliance action plans.
- Conduct GMP/cGMP compliance assessments and identify regulatory gaps.
- Assess the compliance of processes and systems related to Validation, Qualification, CSV, Data Integrity, and Engineering.
- Review validation and qualification documents and ensure their compliance and availability for the inspection.
- Evaluate Data Integrity practices: ALCOA+, Audit Trails, electronic signatures, access management, backup and recovery.
- Supervise the resolution of deviations and ensure the follow-up of corrective actions (CAPA).
- Organize, conduct, and document mock inspections.
- Prepare and support Subject Matter Experts (SMEs) in interviews with FDA inspectors.
- Coordinate Quality, Validation, CSV, Data Integrity, and Engineering teams.
- Monitor KPIs, reporting, and risk escalation to program managers.
- Sector: Pharmaceutical industry
- Regulations: FDA, GMP/cGMP, 21 CFR Part 11, EU GMP Annex 11
- Areas: Validation, Qualification, CSV, Data Integrity, Engineering
- Location: Switzerland
- On-site: 4 days per week
- Start: ASAP
- Duration: until June 30, 2027
- Format: Full-time freelance mission
Project details
- Start: flexible
- Remote: hybrid
- Location: Switzerland, CH
- Languages: French
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