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Devices development and LCM Quality lead
Contracting – Brabant Wallon
Devices development and LCM Quality lead
Functieomschrijving
Design and development Quality assurance:
Vendor quality management:
Quality processes:
Provide expert advice and support on operational and general QA activities for projects part of the devices portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):
General GMP:
- Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
- Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
- Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
- Review and approve the company documentation. Ensure Design History File (DHF) is in place
- Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising.
- Ensure deliverables are issued in accordance with the D&D plan
- Review and approve submissions and responses
Vendor quality management:
- Accommodate design & technology transfer and ensure systems alignment between vendor and the company
- Performing focused assessments/audits
- Preparation and negotiation of Quality Agreements
- Ensure systems alignment between vendor and the company
- Facilitate quality improvement activities at vendors and the company systems
- Support risk register for the vendor, and follow up on mitigation activities
- Monitor and trend vendor performance
- Authority to accept release or block release of Medical Devices
- Oversee inspection plans at CMO and the company
Quality processes:
- Facilitate investigations and resolution of issues relating to deviation and change management
- Review and approve deviations
- Lead/review critical investigations
- Track CAPA events and closure
- Oversee/track change controls
Provide expert advice and support on operational and general QA activities for projects part of the devices portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):
- Act as the Operational QA link between selected external vendors within the Medical Device portfolio
- Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
- Work closely with staff in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way
- Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
- Support additional projects as requested
- Provide on-site presence ‘in plant’ or on site at vendor
General GMP:
- Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
- Drive/Support projects related to quality system improvement
- Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities
- Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
- Support Medical Devices and Combination Products related inspections
- Support Management Review Process
- Support Design Reviews
Profiel
- Master’s degree in Sciences
- Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
- Fluency in French and in English
- Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
- US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Aanbod
- Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres
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