| || Novartis is a world leading healthcare company based in Switzerland providing solutions to address the evolving needs of patients worldwide. Novartis is active in more than 140 countries. More than 1,500 people work for Novartis in Belgium. Novartis has one of the biggest development pipelines due to the high level of investment in R&D.
We are currently looking for a talented person to take on the role of Surgical Logistics Quality Coordinator
In this role, your responsibilities will be as follows:
• Act as a SPOC for the Head Supply Chain and ICDC Puurs and other corporate/international functions, this to enable the department to meet the business objectives.
• To report to/support the Head of CPK QA & Surgical Logistics in all aspects of the role (including budget control and preparation)
• Responsible for the control of quality of the Surgical Hub Warehouse (Bornem)
o Lead escort for external audits (eg Notified Body)
o Manage (immediate) product holds
o Make and maintain/keep up-to-date relevant (corporate) procedures/guidelines/regulations
o Periodical review of warehouse-audits
• Responsible for follow-up of key large projects (eg warehouse systems/ ERP systems) in the Surgical Logistical departments from a QA perspective
• Support Logistical activities for Surgicals from a QA perspective
o Follow-up for timely release of return and redress dossiers
o Responsible for making any relevant monthly reports, quad reports, APR, organizing a quality review for Logistical Surgical QA
o Approval, review and follow-up of product-deviations, external logistical complaints with impact on product-quality
o Evaluation and follow-up of the add-aftering/re-dress process
o Alignment of logistical processes with relevant procedures/regulations
o IGM Business:
- Supporting the Lead IGM Bussiness Coordinator when applicable (eg Record Management); organization of sensibilisation and training concerning Records Management when necessary.
- Ensure correct records Management in the department (like re-quired by the IGM/Records Management Policies, translated in local procedures)
• Supervision of logistical QA team in Surgical Hub Bornem (including providing objectives, coaching and training) and ensure continuity (ensure back-up system).
• Ensure that the QA organization contributes information, knowledge and completes assigned actions within multidisciplinary teams (e.g. risk assessments, change control, audits, batch record review and completion etc.)
• Follow-up and control of SQA related activities concerning Logistical Partners
o Ensure availability of QA Agreements/Risk Assessments with relevant suppliers/contract manufacturers
o Approval and follow-up of complaints, deviations coming from suppliers and contract manufacturers
o Follow-up of a periodical review for suppliers and contract manufacturers
o Planning and follow-up of the screeningsplan of suppliers and contract manufacturers
o When certified for audits: executing of external audits
| || • Industrial engineer or higher (eg bio-engineer, pharmacist)
• English language (fluently speaking and writing)
• Ability to read and understand the French language
• Minimum 5 years of experience in quality and preferably logistic department
• Ability to work decisive and independently
• Ability to give correct and consistent guidance to Logistic QA Engineer(s) and Release Assistant(s)
• Comfortable communicating across different levels within the organisation (eg global roles or head supply chain Puurs and ICDC) in a professional, diplomatic and independent way
• Ability to work quickly, efficient accurately and consistently under pressure, recognizing priorities and required timelines.
• Ability to offer different possible solutions to complex issues and explain pro’s and con’s of the different solutions
• Ability to act with a great sense of responsibility
• GMP knowledge/expertise
• Word, Excell, Access-basis
• Ability to learn other software systems quickly (eg deviation/complaint handling software system)
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 supports a flexible work-life integration.