Quality Sys Spec Iii - Nazareth Eke, België - Bio-Rad Laboratories

Beschrijving

Overview:

As a member of the QA department and backup to the QA Manager you will maintain compliance with ISO13485 and other relevant regulatory requirements, but also Coordinate validation and risk management activities within Bio-Rad RSL and Participate in (improvement) projects within Bio-Rad RSL.

Your Impact:


Validation and risk management:

• Drafting and managing validation plans for equipment, processes, analytical test methods and software.
• Coordinating the implementation of these validation plans.
• Preparation and review of validation protocols and reports.
• Drafting and managing risk management plans for equipment, products, processes and changes to the quality management system.
• Coordinating the implementation of these risk management plans.
• Drafting and reviewing risk analyses in accordance with ISO14971.

Compliance:

• Monitoring compliance with ISO13485 and other relevant regulatory requirements (for medical devices).
• Perform necessary actions to achieve or maintain compliance with ISO13485 or other regulatory requirements.

Projects:

• Participate in various (improvement) projects within the QA department relating to deviations, change controls, complaints,...
• Participate in (improvement) projects within other departments from a QA point of view (review and approval).

QA:

• Draft and follow up on deviations, change controls, complaints (customer, supplier, internal), CAPAs and audits (both internal and external).
• Review and approve Quality Notifications (deviations and supplier complaints) in SAP.
• Reviewing documents belonging to the quality management system (SOPs, work instructions, templates, etc.).
• Provide qualityrelated training within Bio-Rad RSL.
• Backup of the QA Manager for batch release of semifinished and finished goods.

What you bring:

• Master's degree in engineering or sciences.
• Practical experience in performing validation activities (preferably minimum 2 years).
• Thorough knowledge of validation concepts with a focus on equipment and (production) processes (ideally also analytical test methods and software).
• Knowledge of statistics.
• Knowledge of ISO13485, ISO14971, cGMPs and general QA processes (deviations, change controls, complaints, CAPAs, audits) is a plus.
• Knowledge of HPLC is a plus.
• Good communication skills and technical writing.
• Can work efficiently independently and in a team.
• Proficient in standard Microsoft software (Word, Excel, PowerPoint and Visio).
• Languages: Dutch and English.

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare.

As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products.

We help people everywhere live longer, healthier lives.

Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe.

Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits:

Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce.

Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

We're proud to offer a competitive salary with a variety of benefits, including:

• 6 extralegal holidays
• Hospitalisation insurance
• Group insurance
• Meal vouchers
• Eco vouchers
• Annual bonus
• Hybrid working model (3 days on site and 2 home office)

Agency Non-Solicitation:
Bio-Rad does not accept agency resumes, unless the agency has been authorised by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorised to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.