Associate QA Operations Expert

Band

Job Description Summary

Job Description

Key Responsibilities:

• Ensure compliant and timely release of raw materials, bulk products, packaged goods, sterilizations, and imported batches.
• Maintain up‑to‑date expertise in production, sterilization, and release processes relevant to assigned responsibilities.
• Review and assess non‑conformities, support investigations, and define effective CAPAs.
• Contribute to initiatives that reduce deviations and strengthen overall process robustness.
• Monitor file and batch status versus targets and follow up on problem or priority lots.
• Communicate effectively with logistics teams, QC laboratories, and external partners on release‑related matters.
• Provide clear explanations of QA release documentation during internal and external audits.
• Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.

Essential Requirements:

• Master's degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.
• Experience in a regulated environment, preferably within the pharmaceutical industry.
• Strong understanding of Good Manufacturing Practices and relevant pharmaceutical legislation.
• Proficiency in computer systems with the ability to work accurately with digital documentation.
• Excellent communication skills with the ability to collaborate effectively across teams and with external partners.

Desirable Requirements:

• Ability or prior experience to act as a Qualified Person (QP) in accordance with applicable regulatory requirements.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired