摘要
Provide guidance, support and leadership to teams within area of responsibility. Functionally report to QA Operations Lead
About the Role
Major accountabilities:
Operational
- Local SOP initiation
- Documentation Management and archiving
- Training management and compliance tracking
- Support validation activities
- CAPA management and follow up
- Support NDA dossier readiness
- Collaboration in GxP audits/inspections
- Oversight of Quality Operations
- Batch Record review
- QA Operational Excellence
- Complete other tasks be assigned by line manager
- Might run shifts to support product release according to business needs.
HSE
- Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the project
- Ensure overall inspection readiness for area of responsibility.
- Guarantee the effectiveness of the Business Continuity Plan
- Being part of the project crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the project Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.
- Responsible for participating in initial training and retraining
- HSE incidents reporting & action follow-up
Key Performance Indicators
- No project delay caused by the unit
- No critical observations during authority inspections
- No delay with new product introductions caused by the unit
- Timely closing of deviations/complaints
- Achieve project quality budget
- Timely closing of deviations/ complaints.
Ideal Background
Relevant Experience
- Minimum: 3-5 years’ experience in the field of Quality Assurance and
- Sterility Product Manufacturing in a pharmaceutical industry environment or equivalent
- Sufficient experience on audit and inspection preparation and management
- Deeply understanding on cGMP
Education & Qualification
- University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent
Languages
Fluent (oral and written) in English; local language desired
Competencies
- Collaboration; result-oriented
- Advanced communication skills;
- Risk Management
- Audit Management; Health Authorities; Technical Launch and Transfer
- Knowledgeable on GMP Quality Assurance and Manufacturing Process/Product Expertise
- Expertise in GxP operations
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing 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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
