QA Compliance Specialist

About the role

The QA Compliance Specialist supports GxP compliance, audit readiness and quality management at Novartis in Târgu Mureș. The role ensures that business operations, systems and products meet the Novartis Quality Manual, internal policies and regulatory standards.

Key responsibilities

• Execute Quality Assurance activities across the site, ensuring compliance with GMP, GxP, HSE standards and regulatory expectations.
• Monitor quality‑related indicators such as system performance, deviations, non‑conformities and environmental trends.
• Participate in internal and external audits, present the quality system and address audit findings.
• Review, verify and approve documentation for qualification, calibration, validation, maintenance and equipment inventories.
• Ensure validation and compliance of GxP‑impacting computerized systems, including risk assessments, validation plans, test protocols and change control.
• Support operational excellence initiatives using Lean and Six Sigma principles.

Required profile

• Degree in Pharmacy, Chemistry, Chemical Engineering, Medicine, Biology or related scientific field.
• At least 3 years of experience in the pharmaceutical industry in quality, GMP, validation or compliance.
• Strong knowledge of international GMP standards, quality assurance principles and data integrity.
• Good English communication skills.

Required skills

• Proficiency with MS Office and standard IT applications for quality documentation.
• Experience with GxP‑impacting computerized system validation (risk assessments, validation plans, SOPs, audit trails).
• Knowledge of GMP, GxP and quality management systems.

What we offer

• Competitive base salary (RON 84,560 – 157,040 per year) with performance‑based bonus.
• Insurance plans, retirement plans and wellbeing resources.
• Flexible hybrid working options.
• Minimum 14 weeks paid parental leave.