LATAM GDP & GMP Support
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 general 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