- As QA GMP Vendor Specialist you will join a team on client’s site to drive operational Quality Assurance activities at key vendors for commercial Medical Devices and Combination Products, in particular the Quality Management of Design/Technology Transfers for molded parts and assemblies.
- This will be achieved through close partnering with QA management at vendor sites and collaboration with the company's technical operations and teams.
- Perform reviews and approvals of deviation reports, change control reports
- Facilitate investigations, and resolution of quality issues
- Oversee/track change management
- Track CAPA events and closure
- Perform reviews of Manufacturing and control documents
- Review and Approve Device Master Records and any related device specifications
- Provide on-site presence at vendor
- Ensure systems alignment between vendor and the company
- Facilitate quality improvement activities at vendors and the company's systems
- Negotiation and setting of Quality Agreements
- Perform focused assessments/audits
Project support :
- Agree with team activities required for implementation
- Change controls - assessment in TrackWise, track closure of actions to submission approval
- Liaison with Regulatory Affairs
- Review and approve protocols and reports for Verification & Validation studies, Technology transfers, and Stability studies
- Deviation review and approval during Verification, validation and technology transfer
- Company's documentation review and approval
- Work closely with Technical Operations teams to ensure that all QA services are provided in an effective and efficient way.
- Close collaboration with the Device Development QA or transition of projects from development through to industrialisation.
- Support maintenance of the Technical Documentation File
- Support Risk Management Activities related to devices.
General GMP :
- Maintain Quality System elements associated with the GMP activities in a compliant manner.
- Support projects related to quality system improvement.
- Support Device related inspections
- Minimum of 5 years working in the pharmaceutical or Medical Device industry in a GMP operational quality management position.
- Experience interacting with third party organisations with respect to QA systems.
- GMP Auditing expertise
- Understanding & knowledge of the ISO13485 standard & FDA 21 CFR 820 Medical Device Regulations
- Knowledge in Change control
- Documents review and approval
- English is mandatory, French is an asset
- Ability to interact with different stakeholders
- Ability to take initiatives
- Autonomy and flexibility
- Open to travels
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.