QA Manager Operations

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.