Summary
About the Role
Major accountabilities:
- Planning and supporting PQR/APQR activities.
- Support site qualification and validation activities (planning, advising, review).
- Performs preparation and management of external and corporate audits and Health Authority inspections.
- 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 e-Compliance oversight (training, inspections, plan, risk ID etc)
- Ensure process quality assurance acc.
- KPI trending
- Establishment of training system to document all taken trainings and also to retrieve the training status. Ensure organization of GMP training for the site and also to track the completion.
- Preparation and archiving of quality agreements and contracts.
- Manage site quality risk assessments and ensure risks mitigated.
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:
- University degree in Pharmaceuticals, Chemical Engineering or Chemistry
- Minimum 4 years of experience
- Excellent communication skills in English
- Good negotiation skills in English
- Team working and customer oriented mindset
- Good at conflict management
- Knowledge of quality management systems such as deviation, complaint handling, change management
- Knowledge of regulatory systems and CMC processes
- Good analytical thinking and problem solving skills
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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