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Surgical Logistic Quality Coordinator
Responsible for all QA tasks and projects concerning Logistical Operationals Surgicals. This needs to be strictly executed against the relevant procedures of GMP, quality and environment.
- Act as a SPOC for the Head Supply Chain and ICDC Puurs (GJFA 3, Functional Manager) 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 (GJFA 4, Operational Manager) in all aspects of the role (including budget control and preparation)
- Responsible for the control of quality of the Surgical Hub Warehouse In Bornem
- Lead escort for external audits (eg Notified Body)
- Manage (immediate) product holds
- Make and maintain/keep up-to-date relevant (corporate) procedures/guidelines/regulations
- 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
- Follow-up for timely release of return and redress dossiers
- Responsible for making any relevant monthly reports, quad reports, APR, organizing a quality review for Logistical Surgical QA
- Approval, review and follow-up of product-deviations, external logistical complaints with impact on product-quality
- Evaluation and follow-up of the add-aftering/re-dress process
- Alignment of logistical processes with relevant procedures/regulations
- 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 required 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
- Ensure availability of QA Agreements/Risk Assessments with relevant suppliers/contract manufacturers
- Approval and follow-up of complaints, deviations coming from suppliers and contract manufacturers
- Follow-up of a periodical review for suppliers and contract manufacturers
- Planning and follow-up of the screeningsplan of suppliers and contract manufacturers
- When certified for audits: executing of external audits
Skills and personality
- Fluency in English and Dutch and ability to read and understand French
- Minimum 5 years of experience in quality and preferably logistic department
- Experience with independent way of working with great sense of responsibility
- Experience with communicating across different levels within the organisation (eg global roles or head supply chain Puurs and ICDC) in a professional, diplomatic and independent way
minimum 5 years
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