Senior Manufacturing Systems Expert
Il y a 2 mois
The Senior Manufacturing Systems Expert - Master data is responsible for overseeing and organizing site master data and artwork related processes on a day-to-day basis to ensure accurate and timely creation and maintenance of master data/artworks in the ERP system. They are responsible to work with other master data/artwork teams across the organization as the governing body for most data decisions and issue resolutions. They will represent the site in most discussions
**Responsibilities**:
- Build & communicate standards, site SOPs (cookbook and data dictionary procedures) and processes for the daily execution of master data/artwork tasks, supporting the NOCC’s using common methods & tools.
- Responsible to create master data strategy as per change request evaluation in collaboration with the requester
- Support and collaborate closely with the functional site data owners, global master data team (NOCC/MARS), local master data team (NOCC/PEP), AwOps & IT organization to discuss and resolve master data/artwork governance and quality issues. Ensure alignment, continuous and effective communication.
- Continuously supervise progress of site master data/artwork tasks (as per AIP-list and defined Tier KPIs) and delivery of intended results.
- Proactively report all deviations through timely escalations to various stakeholders & ensure implementation of relevant CAPAs and performance improvements.
- Defines and maintains the responsibility and skill matrix (master + backup) within the master data/artwork processes, e.g. the role to raise tickets, the role of data owners, the role to update the SAP system by entering accurate values, etc
- Provides training in support to the contact persons of specific site functions (ticket requester, data owner, etc.) and other stakeholders for specific site master data /artwork processes.
- Responsible for leading and executing complex master data/Artwork Operations projects supporting the NOCCs to ensure compliant artwork/master data creation and master data strategy implementation by providing expertise and process knowledge, coordinating and communicating with different stakeholders and high customer-focus as per SOP and business objectives.
- Ensures compliance with GMP and regulatory requirements and continuous improvement of quality-related processes within the area of responsibility.
- Be Subject Matter Expert of process streamlining, simplification & harmonization by initiating and leading continuous improvement projects to achieve operational excellence.
- Defines the areas for improvement in the field of processes, tools and rules related to master data/artwork, and provides appropriate support with their implementation.
- Subject matter expert for SAP / AwOps / MES
- Develop on-site expertise
- SPOC for major trouble shooting, CAPA execution and change controls management
- Work under Novartis Quality and HSE standards, procedures and policies
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- Minimum 5 year experience in GMP manufacturing
- Preferably minimum 3 year experience in an Data Expert role in GMP environment
- University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience
- Fluent in Dutch and English
- Good oral, written and presentational skills
- Team player with ability to foster stakeholder Engagement
- Objective Setting and Performance Management, Lean Management
- Good negotiator, Influencing and persuading
- Change management, adaptability, ability to work under pressure
- Quality and compliance focus
- Project management /statistical analysis tools/ operational excellence
- Good understanding of regulatory requirements across multiple health authorities
- Good working knowledge/understanding of manufacturing execution systems (SAP, or other as applicable)
You’ll receive:
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules,...). Your office will be based in Puurs. Locally, we offer benefits to ensure our associate's mental and physical well-being. There is a fitness available for our associates to use and we offer a bike-leasing program. We have a mental coach on site as well.
Why consider Novartis?
769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s
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