Novartis
pharmaceutical
QualityOperationsSpecialist
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Operations Specialist at Novartis. Skills: batch release activity, Regulatory Compliance Check for batches, cGMP (Current Good Manufacturing Practices), GxP documents, SOPs, Stakeholder management, Project coordination, Quality Assurance, Quality Control, Regulatory. Perform batch release activity to support stakeholders in overall management of their projects. Regulatory Compliance Check for batches and their release in SAP”
What You'll Achieve.
Perform batch release activity to support stakeholders in overall management of their projects; Ensures that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures; Focus on timely completion of all relevant and assigned training and ensure responsibility and ownership of the assigned tasks; Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
Industry & Context.
Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures; Problem Solving Skills
What They're Looking For.
Must Have
B. Pharm/ M. Pharm/MSc/equivalent from a reputed institute, Minimum 2-4 years’ experience in Quality Assurance, Quality Control, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system, Basic awareness of GxP compliance requirements, English fluent, written and spoken, Stakeholder management and good communication with stakeholders, Technological Expertise and intelligence, Project coordination, Proficiency in MS Office tools
Nice to Have
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge
What You'll Do.
Perform batch release activity to support stakeholders in overall management of their projects
Regulatory Compliance Check for batches and their release in SAP
Ensures that the operational business is in compliance with cGMP (Current Good Manufacturing Practices)
the Quality Assurance Agreement
regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
Supports in batch release preparatory activities and timely implementation for new projects
Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
Assist the department on any other ad hoc activities/ requests to meet the business requirements
Regularly communicate with partners and obtain feedback on services delivered
Focus on timely completion of all relevant and assigned training and ensure responsibility and ownership of the assigned tasks
Create and review GxP documents including SOPs
qualification reports and technical investigations
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
Provide active support during internal and external audits by collecting and presenting the requested process data/reports
Support implementing service quality and process improvement projects
CAPA management within Quality Service Centre
Perform regulatory compliance checks and Batch Document Review as per the defined process
Create and review GxP documents
such as mismatch trend reports and send it to the stakeholders
Preparatory activities support for Batch release to required sites
How You'll Work.
Team & Collaboration
Regularly communicate with partners and obtain feedback on services delivered; Provide active support during internal and external audits by collecting and presenting the requested process data/reports; Collaboration
Communication Scope
English fluent, written and spoken; Stakeholder management and good communication with stakeholders; Communication Skills
Process & Methodology
Project coordination, Support implementing service quality and process improvement projects
Full Job Description
**Job Description Summary** The Quality Operations Specialist performs batch release activity to support stakeholders in overall management of their projects. Regulatory Compliance Check for batches and their release in SAP. Ensures that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Supports in batch release preparatory activities and timely implementation for new projects. **Job Description** **Major Accountabilities** * Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows. * Assist the department on any other ad hoc activities/ requests to meet the business requirements. * Regularly communicate with partners and obtain feedback on services delivered. * Focus on timely completion of all relevant and assigned training and ensure responsibility and ownership of the assigned tasks. * Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed. * 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. * Provide active support during internal and external audits by collecting and presenting the requested process data/reports. * Support implementing service quality and process improvement projects, CAPA management within Quality Service Centre. * Perform regulatory compliance checks and Batch Document Review as per the defined process. * Create and review GxP documents, such as mismatch trend reports and send it to the stakeholders. * Preparatory activities support for Batch re
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