Belgium Job Openings
BVI Medical
QA Design & Control Officer
Liège
FULL TIME
October 3, 2024
Job Requisition No
VN8083
Work Location Name
Belgium - Liege
Worker Basis
Full Time
Worker Type
Employee
Applications Close Date
Dec 31, 2024
Purpose
Ensure by Quality oversight the Validation processes from the Design of a product to the Continuous Verification of manufacturing processes and product quality for all the GMP systems of the Liège site: equipment, rooms, production processes, test methods, computerized systems, utilities, environmental monitoring …Assess and challenge the Validation Quality Systems in place and participate to the optimization of it in collaboration with the R&D, Industrialization and Manufacturing/Technical Services departments.
Key Responsibilities
- Supervise the Quality aspects the Validation and Qualification projects and related routine activities conducted in R&D, Industrialization and Manufacturing/Technical Services departments of the Liège site
- Approve the Validation strategies in line with the regulations and business needs
- Ensure that the local Validation Quality System is in line with the Gx P and internal requirements
- Be the Quality representative during Quality inspections and external audits, ensure the “inspection readiness” of the departments in charge of the Validation executions
- Act as a SME for the Risk Management System related to the Validation activities
- Ensure the effective implementation of the BVI Quality Management System including Deviation/NC, CAPA, Change Control, Audits and Management Review across the 3 entities
- Ensure and follow-up the Quality metrics/KPI’s related to the Validation activities across the 3 entities
- Ensure critical topics are adequately and timely escalated to higher management
- Actively participate or be involved in the continuous improvement activities
- Perform analysis and generate recommendations for Senior Management
- Other duties as required
Qualification
Education/experience:
- Excellent communication skills (oral and written) - English language mandatory
- Has Ability to work collaboratively in cross-functional teams to achieve milestones and goals
- Ability to influence and negotiate
Education/experience:
- Master or Bachelor degrees in Technical or Life Sciences
- More than 5 years of Quality experience in Med Tec or Pharma Industry
- More than 3 years of experience in Validation/Qualification activities
Company
BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and Phys IOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and Phys IOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
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