Engineering Qualification Manager

Experteer Italy; Latina; In loco; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking an Engineering Qualification Manager at their Latina site. The role involves overseeing qualification activities, ensuring compliance with GMP regulations, and managing departmental coordination. Ideal candidates have a degree in a relevant field, 5 years' experience, and proficiency in English. Enjoy a culture of creativity and responsibility in a highly competitive environment.

Competenze

• Minimum 5 years' experience in qualification/validation in pharmaceutical companies.
• In-depth knowledge of GMP, GAMP, FDA, EMA standards.
• Knowledge of English (B2) required.

Mansioni

• Oversee qualification activities according to GMP regulations.
• Coordinate qualification activities across departments.
• Ensure compliance and integrity of data during activities.

Conoscenze

Precision

Attention to detail

Interpersonal skills

Cross-functional teamwork

Formazione

Degree in scientific or engineering disciplines

Strumenti

MS Office

Document management systems

ERP

Descrizione del lavoro

Engineering 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