Summary
-Performs preparation and management of external and corporate audits and Health Authority inspections.
About the Role
Major Accountabilities:
- Planning and supporting PQR/APQR activities.
- Support site qualification and validation activities (planning, advising, review).
- Implementation of Quality Systems (incl. documentation management)
- Supplier management activities (agreements, oversight, audit).
- Preparation/support and coordination of CAPA/follow -up
- Audit and inspection preparation and support
- Change control review/approval
- Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance acc. to regulations
- QP declaration review and approval
- KPI trending
- Ensure applications, certificate maintenance etc. to local HA
- SPOC for communication with HA, GCA / One voice /consolidated approach / synergies for all sites within same HA jurisdiction / country
- 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:
- Successful support of projects with agreed quality and delivery dates, passing of internal & external inspections.
- Meet quality & timelines for all projects
- Act in accordance with Novartis standards.
- The number and severity of cGMP issues identified during internal and external audits
- Year-end figures within budget; Successful coordination of departmental operational activities
Work Experience:
- Budget Management
- Change Control Management
- Audit & Inspection Management
- Compliance Risk Management
- Good Manufacturing Practices (cGMP)
- GxP Experience
- KPI Reporting
- People Management
- Quality Assurance
- Quality Management System
- Record Management
- Quality Compliance
Skills:
- Dealing With Ambiguity
- Decision Making
- Organizational Saviness
- Leadership
- Risk Management
- Collaboration
- Regulatory requirements knowledge
- Communication skills
- Data Integrity
- Digital saviness
Languages:
- English.
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Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
