QA Equipment Validation Specialist

SwissCo Services AG / Aenova Group; Latina; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Latina, Italy is seeking a QA Equipment Validation Specialist to ensure compliance with industry regulations and guidelines. The ideal candidate has a degree in a scientific field and prior experience in validation within the pharmaceutical industry. Responsibilities include maintaining documentation and acting as a contact during audits. The company values a solution-oriented culture and offers competitive benefits.

Competenze

• Previous experience in the pharmaceutical industry is highly valued.
• 2–3 years of experience in qualification/validation within pharmaceutical companies.
• In-depth knowledge of GMP, GAMP, and major international standards.

Mansioni

• Provide expertise in validation, ensuring compliance with industry regulations.
• Review and approve qualification and validation protocols, reports, and documentation.
• Act as point of contact for customers during audits and inspections.

Conoscenze

Expertise in validation

Excellent interpersonal and communication skills

Strong attention to detail

Technical documentation skills

Strong IT skills (MS Office, ERP)

Formazione

Degree in a scientific or engineering discipline

Descrizione del lavoro

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!

We are open to your questions. Contact Lukas Rödder / Human Resources for more information.