| Quality |
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- Assess the conformity to Best Practices (GXP*, ISO 9001, ISO 14 001)
- Perform GMP / GDP support such as: auditing (self-inspection, suppliers, sub-contractors), writing APQR, SMF and Quality Agreements, setting up documentation systems
- Perform GCP/GLP support for audits of investigator’s sites, CROs and clinical pharmacies and laboratories
- GXP* training and continuing education
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- Evaluate, conceive and complete regulatory files (EMEA, FDA, ICH)
- Propose areas of improvements through efficient internal processes and KPIs
- Complete and mitigate a multi-sector risk analysis to provide a simple decision tool kit
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