QA Operations Lead

Summary

• Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures

About The Role Major Accountabilities:

• Functional Breadth, Critical Negotiations, People Leadership, Operations Management and Execution, Collaborating across boundaries, Project Management
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key Performance Indicators

• On-time & GMP-compliant release of dosage forms
• No Complaints about inspections by authorities in your own area of responsibility without these being noticed & communicated beforehand.
• Successfully Support continuous improvement Projects
• Executes batch release in compliance with registration
• As per local regulatory requirement and global guidance/SOP to set up local documentation hierarchy
• Quality system management (e.g., Change Control, Deviation, Audit &Inspection, CAPA, QE, CONDO, etc.)
• Validation Batch Record review; Validation protocols review; Deviation management; On site Quality monitoring
• Support and oversight validation activities
• Audit and Inspection preparation and readiness
• Function representative to be involved in global and/or local project if any.
• Collaboration in GxP audits/inspections
• Oversight of Quality Operations
• Master Batch Record review and approval
• As site QP or delegation to release product
• QA for Quality Control & AS&T
• QA Operational Excellence

Work Experience

• Good Manufacturing Practices (cGMP)
• Audit & Inspection Management
• Release Management
• Quality Assurance
• Quality Compliance
• Quality Management Systems
• Technological Expertise

Skills

• Collaboration
• Continuous Improvement mindset
• Dealing With Ambiguity
• Regulatory requirements knowledge
• Problem Solving Skills
• Leadership
• Communication skills
• Data Integrity
• Digital savviness

Languages

• English.

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