Specialist - Quality Operations

• 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.

Collaboration, Communication, Data Integrity, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)

Level 3

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

• 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.

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

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