Quality Engineer - Qualified Person

Labcorp; Antwerpen; Sur place; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote working

Career progression

Well-being programs

Résumé du poste

Labcorp in Mechelen, Belgium, seeks an onsite Quality Engineer - Qualified Person to join our new CMC facility. You will implement and maintain QMS, lead QA activities, and oversee validation and regulatory compliance across studies and release.

Fluency in English and Dutch is required; a Master in Pharmacy; and a Certified Qualified Person by FAMHP are expected. This is a global organization with strong development opportunities.

Qualifications

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

Responsabilités

• 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.

Connaissances

Fluency in English and Dutch

Formation

Master's degree in Pharmacy

Bachelor's degree in life science

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

Additional Job Standards

• Fluency in English and Dutch
• 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. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK), and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. 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.

We encourage all to apply

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