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:
- Ensures planning and successfully supports PQR/APQR activities -Successfully carries out site qualification and validation activities (planning, advising, review) -Supports the implementation of Quality Systems (incl. documentation management); Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc) -Ensure process quality assurance according to regulations
Minimum Requirements:
Work Experience:
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- cleanliness zones.
- Functional Breadth
Skills:
- Action Oriented.
- Continuous Learning.
- Dealing With Ambiguity.
- Functional Skills.
- Gmp Procedures.
- Process Optimization.
- Qa (Quality Assurance).
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
- GxP.
- Industry standards.
- Compliance requirements.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
