Descrizione:
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.
Responsibilities
Provide expertise in validation, ensuring compliance with industry regulations, guidelines, and trends.
Review and approve qualification and validation protocols, reports, and related documentation, including premises, equipment, and utilities.
Prepare and maintain validation-related SOPs and policies; assess change controls for validation impact.
Troubleshoot validation deviations, participate in revalidation programs, and support cross-functional projects as QA validation representative.
Maintain organization and archival of all validation and qualification documentation.
Act as point of contact for customers during audits, inspections, and validation-related discussions, ensuring professional and solution-oriented communication.
Profile
Degree in a scientific or engineering discipline (e.g., Chemistry, Biotechnology, Engineering, Pharmaceutical Chemistry).
Previous experience in the pharmaceutical industry is highly valued and essential for this role.
2–3 years of experience in qualification/validation within pharmaceutical companies.
Experience in sterile manufacturing (Fill & Finish) is a strong advantage.
In-depth knowledge of GMP, GAMP, and major international standards (FDA, EMA).
Strong technical documentation skills, attention to detail, and ability to work independently.
Excellent interpersonal and communication skills, with confidence in direct customer interactions.
Team-oriented mindset and strong IT skills (MS Office, ERP, document management systems).
Note
Please note:
Applications
must be submitted in English . Applications in Italian or any other language will
not be considered .
Haupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT, Italy
#J-18808-Ljbffr