Labcorp
BioPharmaceutical
GMPQualitySpecialist
Neural analysis suggests this role is
optimal for Mid candidates.
“GMP Quality Specialist at Labcorp. Skills: GMP Quality Assurance, Validation, CAPA, Change Control. Participate in projects for validation and qualification. Review metrology methods and specifications”
What You'll Achieve.
Ensure facilities, utilities, equipment and computer systems are appropriately validated & qualified; Ensure accuracy / relevance and compliance with appropriate quality standards; Ensure compliance with applicable regulations; Improve efficiency / effectiveness of GMP operations
Industry & Context.
Problem Solving; Root Cause Investigations; Risk Assessments
What They're Looking For.
Must Have
Bachelor’s Degree, e. g. Biology, Chemistry, Pharmacy, or relevant Engineering discipline, 3 or more years of experience in GMP Quality Assurance role in an analytical testing or manufacturing environment, Experience with CAPA, change control, deviations, pharmaceutical QC testing methodologies and equipment validation procedures, Fluency in English and Dutch
Nice to Have
Higher level qualification and/or equipment management /regulatory qualifications, 2 or more years experience working in GMP compliant QC analytical laboratory environment, 3 or more years of experience in GMP Quality Assurance role, 2 or more years of experience in equipment validation and qualification, Understanding of applicable regulations and quality management systems / principles, tools, and standards, Detail oriented with knowledge of quality metrics and previous auditing experience preferred, Good interpersonal / organizational skills, e. g. communication, decision making, problem solving, data analysis, negotiating, influencing, Customer service oriented
What You'll Do.
Participate in projects for validation and qualification
Review metrology methods and specifications
Approve Quality Related Issue Resolutions
Facilitate root cause investigations
Review and approve pharmaceutical GMP studies
Monitor and report quality metrics
Participate in regulatory training development
Support the annual audit program
Support validation and verification activities
Contribute to continual improvement initiatives
Review and approve site-based controlled documents
Ensure RC&QA responsibilities are followed
How You'll Work.
Team & Collaboration
Work with product team; Support external vendor assessments; Provide back room assistance during inspections
Communication Scope
Communication; Decision Making; Problem Solving; Data Analysis; Negotiating; Influencing
Process & Methodology
Planning audits
Full Job Description
Labcorp is looking for an onsite **GMP QA Specialist** for our new CMC facility in Mechelen, Belgium. **Job Responsibilities:** * Participation in projects to ensure facilities, utilities, equipment and computer systems are appropriately validated & qualified, including review and approval of key validation deliverables. * Review of metrology methods and specifications for accuracy / relevance and compliance with appropriate quality standards * Participates in and approves Quality Related Issue Resolutions, Corrective / Preventive Actions (CAPA), Change Controls, Vendor Management and Complaint Handling, Continual Improvement, as appropriate. Facilitation of root cause investigations / risk assessments and engineering solutions to address process quality issues * The review and approval of pharmaceutical GMP studies: Providing regulatory review of study related documentation (e.g. methods, protocols, reports, certificates of analysis, etc.). * 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 * Participate in the development / delivery of regulatory based training including quality management principles and risk management practices. * Supports the annual audit program by planning, leading, reporting and following up of internal audits, supporting external vendor assessments and providing back room assistance during hosted regulatory and client inspections * Study Specific oversight for Pharmaceutical GMP Studies: Provides regulatory review of study related documentation (i.e. methods, protocols, reports, certificates of analysis, etc.) * Support validation and verification activities, including but not limited to protocol development and execution and deviation / non-conformance resolution; review of key validation deliverables * Contributes to continual improvement initiatives aimed at improving the efficiency / effectiveness o
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