QA Compliance Specialist — GMP, Validation & Audits

IT08 (FCRS = IT008) Novartis Farma S.p.A.; Torre Annunziata; Hybrid; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Hybrid working options

Parental leave (14+ weeks)

Insurance plans

Job summary

Novartis Farma S.p.A. is seeking a QA Compliance professional to oversee quality systems, data integrity and regulatory compliance across key site activities in Italy. You will manage PQR/APQR, supplier oversight, CAPA, audits, and change controls, ensuring GMP adherence.

Fluency in Italian and English and 3–5 years in QA are required. The role emphasizes collaboration, training oversight, and timely reporting of adverse events, with a hybrid working model and competitive compensation in line

Qualifications

• University degree in a relevant field.
• 3–5 years of experience in a QA Compliance role within the pharmaceutical industry.
• Strong collaborative attitude and stakeholder management skills.
• Fluent in Italian and English.

Responsibilities

• Plan and support PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implement Quality Systems (documentation management).
• Oversee supplier management (agreements, oversight, audit).
• Prepare/support CAPA and follow-up.
• Assist audits and inspections preparation and support.
• Review/approve change controls.
• Ensure local DI and eCompliance oversight (training, inspections, risk ID).
• Report technical complaints/adverse events related to Novartis products within 24 hours.

Skills

QA Compliance

Audits

Data Integrity

Regulatory Compliance

Validation

Quality Management

Education

University Degree in Pharmacy, Biotechnology, Chemical Sciences or related field

Job description

Novartis Farma S.p.A. is seeking a QA Compliance professional to oversee quality systems, data integrity and regulatory compliance across key site activities in Italy. You will manage PQR/APQR, supplier oversight, CAPA, audits, and change controls, ensuring GMP adherence.

Fluency in Italian and English and 3–5 years in QA are required. The role emphasizes collaboration, training oversight, and timely reporting of adverse events, with a hybrid working model and competitive compensation in line