10 Capa Documentation Jobs

Role Overview: As the Head of Clinical Operational Excellence at Novo Nordisk, you will be responsible for ensuring clinical quality, compliance, and operational excellence. Your role will involve performing risk assessments and trend analyses to address clinical quality risks proactively, ensuring audit and inspection readiness, representing the CDC in regional and global clinical quality forums, coordinating Quality Management Reviews (QMR), driving innovative solutions for operational efficiency, and implementing process improvements. You will play a key role in communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO, and ensuring compliance with local regulatory requirem...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Level: L2+L3 L2 (Experience 3-5 Years, Incase not explicitly mentioned) Log and manage Problem Management (PM) tickets with end-to-end ownership in SNOW. Coordinate initial problem records with relevant SMEs and CUSTOMER SPOCs. Automate PM workflows and dashboards in SNOW. Lead weekly and monthly governance meetings to analyze trends and recurring issues. Identify potential problems through trend analysis, incident patterns, and RCA. Drive RCA and CAPA submissions within defined timelines. Coordinate change management for deploying permanent fixes. Continuously improve PM processes based on lessons learned. Publish monthly PM reports and dashboards, and weekly reports to resolver groups. Mai...

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder...