Analyst-Quality Operations

Common Accountabilities (Applicable to all service teams)

• Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
• Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables
• Generate and analyse predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required
• Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
• Assist the department on any other ad hoc administrative activities as per business requirements.
• Focus on timely completion of all relevant and assigned trainings
• Learn & develop understanding to generate insights through data and digital
• Ensure responsibility and ownership of the assigned tasks
• Comply the accuracy and timeliness of deliverables
• Comply to the applicable Novartis operating procedures as per legal / IT / HR requirement
• Provide active support during internal and external audits by collecting and presenting the requested process data / reports
• Adhere to the current GxP and compliance policies of Novartis.

ROLE SPECIFIC ACCOUNTABILITIES ACROSS ALL FUNCTIONS IN QOP

Annual Product Quality Review

Ideal Background / Requirements for the role

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Skills Required

Quality Control, Quality Assurance, Regulatory, Quality Standard