Quality Engineer - Qualified Person

BVB Labcorp BV; Mechelen; Hybride; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Remote working

Résumé du poste

Labcorp seeks an onsite Quality Engineer - Qualified Person to join our brand new CMC facility in Mechelen, Belgium. This role centers on implementing and maintaining a robust quality management system that meets domestic and international regulations, while coordinating CAPAs, change controls and regulatory inspections.

The successful candidate will lead QA activities, supervise a segment of the QA team, and ensure validation/qualification of facilities, utilities and computer systems in line

Qualifications

• Certified Qualified Person by FAMHP is required.
• Master degree in Pharmacy is required.
• 3+ years of quality-related work experience.

Responsabilités

• Supports implementation of a quality management system complying with domestic and international regulations.
• Ensures local compliance with QMS requirements.
• Oversees CAPA, Change Controls, Vendor Management and complaint handling.
• Leads QA team activities, including training and development.
• Represents QA on projects and supports regulatory inspections.

Connaissances

Quality management

Regulatory compliance

Leadership

Formation

Master degree in Pharmacy

Certified Qualified Person by FAMHP

Description du poste

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Labcorp is seeking an onsite Quality Engineer - Qualified Person to join our brand new CMC facility in Mechelen, Belgium.

Job Responsibilities

• Supports the implementation of a quality management system that complies with domestic and international regulations.
• Ensures local compliance with the QMS requirements.
• Plays a leading role in the implementation of a quality management system that complies with domestic and international regulations.
• Ensures local compliance with the QMS requirements.
• Oversees, and approves Quality Related Issue Resolutions, Corrective / Preventive Actions (CAPA), Change Controls, Vendor Management, Complaint Handling, Continual Improvement and NCM/MRB systems, as appropriate.
• Engineers solutions to address product and process quality issues.
• Supervisory responsibility for a segment of the QA team providing workload assignment, recruitment, performance evaluation, professional and personal training and development, implementation and follow-up of site departmental objectives, etc.
• May deputize for the Site QA Lead.
• Monitors, compiles and reports on appropriate quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process; assess and report post-market surveillance data in accordance with regulatory requirements.
• Promote awareness of the applicable regulations and associated quality management system and lead the development / delivery of regulatory based training including quality management principles and risk management practices.
• Supports the annual audit program by scheduling, planning, leading, reporting and following up of internal audits, leading/supporting external vendor assessments and hosting regulatory and client inspections.
• Study Specific Oversight - Pharmaceutical GMP Studies: Provides regulatory approval and accountability for release (or rejection) of study related documentation (i.e. batch records, methods, protocols, reports, certificates of analysis, etc.) and/or pharmaceutical material/product for use in clinical trials.
• Represents QA on key projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables Reviews and approves controlled documents (SOPs, Policies, etc.) to ensure compliance with applicable regulations, document management procedures and other relevant quality standards Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
• Where needed provides QP confirmation statements for associated certificates of analysis.
• Other duties as assigned by management.

Minimum Qualifications

• Certified Qualified Person by FAMHP
• Master degree in Pharmacy
• 3 or more years experience in quality-related work

Preferred Qualifications

• Bachelor degree in life science
• 3 or more years of experience in working with quality management systems and applicable regulations
• 1 or more years experience in pharmaceutical or biotech industry in a global organization
• 1 or more years experience in clinical research

Eligible to be named on a Belgian Manufacturing and Importation Authorization limited to QC testing.

Excellent leadership and interpersonal / organizational skills, e.g. communication, decision making, problem solving, data analysis, negotiating, influencing Customer service oriented Preferably holds a relevant quality accreditation such as Lead Auditor Certification, Quality Engineer Certification, Sigma Black Belt.

What Labcorp can offer you:

• Competitive salary and comprehensive benefits package including target incentive plan
• Remote working
• Excellent career progression and development opportunities within a supportive team
• A culture of CARE with access to well‑being programs and various employee resource groups

Labcorp is expanding its global BioPharmaceutical Chemistry, Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen, Belgium. Biopharmaceutical CMC provides independent, objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients. With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization, method development, stability and routine QC release for biologics, vaccines, ATMP’s, and a breadth of other complex biomolecules. With this new laboratory in Belgium, we aim to offer a more comprehensive solution and accelerate the availability of new products for patients.

If you would like to join us and be a part of this exciting journey, take a look at the fantastic opportunities we have to offer. This is a unique opportunity to shape a new site, solve problems, and lead local operations within a global quality framework.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement. We believe in the power of science to change lives. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.