摘要
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 and external inspections.
- Meet quality and 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
Minimum Requirements:
Work Experience:
- Functional Breadth.
- Collaborating across boundaries.
- Project Management.
- People Leadership.
Skills:
- Audit Management.
- Auditing.
- Communication Skills.
- Compliance Audits.
- Compliance Risk.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gmp Procedures.
- Inspection Readiness.
- Organizational Skills.
- People Management And Leadership.
- Qa (Quality Assurance).
- Regulatory Compliance.
- Risk Management.
- Self Awareness.
- Technological Expertise.
Languages :
- English.
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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
