Project Start Date:
November 1, ****
Project End Date:
July 31, **** (9 mos.)
Background
GDP sites in Peru, Chile and Argentina but are planning to comply with Pharmaceutical GDP (Cold Storage) as well
Location
Argentina (highly preferred), Chile, or Peru
Must Have Requirements
Must have knowledge of Argentina, Peru and Chile local GDP/GMP requirements
Must be a Technical Director and have a Pharmacist Title as this is required by law
SCOPE
Gap Assessment on GDP and GMP for their QMS in Peru, Chile and Argentina (+/- 40 SOPs)
1 day / 1 auditor on site GDP audit - 3 sites; Inspection readiness
1 day / 1 auditor on site GMP audit - 3 sites; Inspection readiness
Training of staff
Qualification and Validation of warehouse and equipment
CSV - most systems used are integral and have been validated but need to be validated for these countries (Argentina, Chile, Peru) as well
#J-*****-Ljbffr

📌 Technical Director (Buenos Aires)
🏢 ProPharma
📍 Buenos Aires