Specialist Quality Operations

• Provide quality support in compliance with cGMP requirements and Novartis Quality Management System. Manage Quality aspects & projects within area of responsibility.

Major accountabilities:

• Have expertise in Supplier Quality management and QMS activities. Drafting of QRA, QAA and AMR documents. Handling Supplier Qualifications and change notification.
• Interpret and compile APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification
• reports and technical investigations, as and when needed.
• Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports
• Adherence to the current GxP and compliance policies of Novartis 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, TEDI etc.) to ensure
• appropriate execution of service deliverables
• Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed
• product quality standards and service level agreements
• Support implementing service quality and process improvement projects, CAPA management within
• Quality Service Centers
• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket
• management tools and other internal systems and processes

• Minimum 6 years of experience in Quality assurance activities in pharmaceutical company.
• GxP knowledge, Basic IT knowledge
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

• English.