QA Compliance Specialist - GMP, Validation & CAPA (Hybrid)

Novartis Italia; Torre Annunziata; Hybrid; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Flexible and hybrid working options

Minimum 14 weeks parental leave

Job summary

Novartis Italia is seeking a QA Compliance professional to oversee quality systems, data integrity, and regulatory compliance at the site. You will coordinate PQR/APQR activities, assist qualification and validation, and manage supplier oversight and CAPA processes in line with GMP requirements.

The role requires a degree in a related field and 3–5 years’ QA compliance experience, with fluency in Italian and English.

Qualifications

• University degree in Pharmacy, Biotechnology, Chemical Sciences or related field.
• 3–5 years of experience in a QA Compliance role within the pharmaceutical industry.
• Fluent in Italian and English.
• Strong collaborative attitude and stakeholder management skills.

Responsibilities

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management).
• Supplier management activities (agreements, oversight, audit).
• Preparation/support and coordination of CAPA/follow-up.
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID).
• Ensure process quality assurance acc. to regulations.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.

Skills

Collaborative attitude

Stakeholder mgmt

Bilingual Italian/English

Education

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

Job description

Novartis Italia is seeking a QA Compliance professional to oversee quality systems, data integrity, and regulatory compliance at the site. You will coordinate PQR/APQR activities, assist qualification and validation, and manage supplier oversight and CAPA processes in line with GMP requirements.

The role requires a degree in a related field and 3–5 years’ QA compliance experience, with fluency in Italian and English.