Qualification Manager
for the site Borgo San Michele LT, Italy
Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.
Your key responsibilities
* Oversee the qualification activities of plants, equipment, classified environments and critical systems according to GMP regulations.
* Oversee the coordination of qualification activities with the departments involved: Engineering, Production, Quality, Maintenance and HSE.
* Quantify the budget.
* Provide the necessary support during internal and external audits, regulatory inspections and periodic review activities of qualified systems.
* Ensure the traceability, compliance and integrity of data generated during qualification activities.
* Monitor the qualification status of corporate assets and manage the life cycle of systems according to corporate policies.
Your profile
* Degree in scientific or engineering disciplines (e.g. Chemistry, Biotechnology, Engineering, Pharmaceutical Chemistry and Technology).
* Minimum 5 years' experience in the field of qualification/validation in pharmaceutical companies.
* In-depth knowledge of GMP, GAMP and major international standards (e.g. FDA, EMA).
* Precision, attention to detail and ability to manage activities independently.
* Good interpersonal skills and ability to work in cross-functional teams.
* Knowledge of English (B2).
* Proficiency with the main IT tools (MS Office, document management systems, ERP).
Your motivation
Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively
and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather
than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal
conversation
If you have any questions, I - Chiara Fanasca / Human Resources - will be happy to help you:
Haupt Pharma Latina S.r.l.
• Member of the Aenova Group
• Strada Statale 156 dei Monti Lepini
• 04100 Borgo San Michele LT, Italy