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QA Equipment Validation Specialist

3 ore fa

Latina Italy Haupt Pharma Latina A tempo pieno
QA Equipment Validation Specialist
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
  • 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.
Your 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).
Please note: Applications must be submitted in English. Applications in Italian or any other language will not be considered.

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 - Lukas Rödder / 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