Specialist - Quality Operations

Band Level 3

Job Description Summary The Specialist - Quality Operations supports in batch release preparatory activity, QMS activity and Regulatory compliance check.

Major accountabilities:

- Perform Quality Operations activities supporting product quality, batch release, and regulatory compliance processes.

- Execute batch release preparatory activities, technical release verification, and regulatory compliance checks according to defined procedures.

- Ensure compliance with GxP requirements, Novartis quality standards, regulatory requirements, and internal operating procedures.

- Create, review, and maintain GxP documentation, including SOPs, working procedures, trend reports, investigations, and qualification reports.

- Support Quality Management System (QMS) activities, including deviation management, quality events, and compliance follow-up actions.

- Generate, analyze, and interpret reports from approved systems to drive operational monitoring and informed decision-making.

- Support master data management, BOM approval activities, Certificate of Analysis (CoA) generation, and other quality-related processes.

- Escalate and support the investigation of GxP and non-GxP issues, ensuring timely resolution and compliance.

- Provide support during internal and external audits through data collection, reporting, and presentation of quality documentation.

- Deliver accurate and timely results while supporting KPI reporting, digital/data-driven initiatives, and additional business or departmental requirements.

Essential requirements:

- Bachelor's or Master's Degree in Pharma or equivalent.

- 5-7 years of experience within a GMP Quality Assurance department with a focus on batch release activities.

- Experience with QMS processes, particularly deviations, quality events and compliance activities.

- Exposure to regulatory compliance or regulatory affairs activities.

- Clear and effective communication in English.