Consultant en Qualification et Validation dans le domaine de la santé, responsable de la coordination et de l'exécution du cycle de validation pour les projets de production de médicaments ou de produits liés à la santé.
Responsibilities
Représenter le département Validation sur les différents projets
Concevoir et mettre en œuvre la meilleure stratégie de Validation
Coordonner la planification du projet avec toutes les parties prenantes
Participer à l’évaluation des risques via la rédaction d’un « Risk assessment »
Contribuer à la définition et à la rédaction des Functional Specifications (FS) et Design Specifications (DS)
A C&Q/CSV Specialist responsible for ensuring compliance with regulatory requirements, GMP, and pharmaceutical policies through commissioning, qualification, and computer systems validation activities.
Responsibilities
Ensure the site validation program has been developed and maintained in compliance with regulatory and corporate requirements and Master Plans.
Work with qualification teams on requirement, design review, construction, qualification, and documentation strategies.
Review and approve commissioning and qualification documentation, including URS, IQ, OQ, and PQ protocols and reports, SOPs, and Work Instructions.
Review and approve validation protocols and reports (analytical, cleaning, process, etc.).
Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and regulatory requirements.
Requirements
Bachelor's degree in a scientific or engineering discipline
Draft and implement Quality System documentation, author validation protocols, coordinate validation activities, provide input on equipment requirements, support technology transfer, and ensure compliance with regulatory and quality standards.
Compensation
The salary range for this position ranges from $103,000 - $115,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months.
Responsibilities
Draft and implement Quality System documentation including SOPs and Traceability Matrix
Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines
Coordinate all validation activities with vendors, analyze and assemble results, and draft validation reports
Provide input on user and/or functional requirements of current and future processing equipment
Interface with Contract Manufacturers to ensure all relevant user and functional requirements are met
Seeking a highly qualified Senior QA Specialist to join a new Biotherapeutics Manufacturing facility in Wilson, NC, ensuring compliance with regulatory requirements and GMP policies throughout the C&Q validation lifecycle.
Responsibilities
Represents Quality Assurance on qualification teams and provides QA oversight of C&Q and validation execution across the capital project lifecycle—user requirements, design review, construction, FAT/SAT, commissioning, qualification and handover.
Supports development and maintenance of site validation program, Validation Master Plan, and project C&Q and validation plans.
Participates in risk assessments (FMEA, HACCP, HAZOP, ICH Q9(R1), CARA) for equipment, utilities and systems.
Reviews and approves commissioning and qualification documentation, including URS, FAT/SAT, IQ/OQ/PQ protocols, and reports.
Ensures Good Documentation Practice and data integrity of vendor, EPCM and CQV contractor documentation.
Requirements
Bachelor's degree in a scientific or engineering discipline
Master's degree in a scientific or engineering discipline
Nice to have: greenfield or start-up facility experience
Supervisor of Quality Control (QC) Lab Operations to support a highly automated drug substance manufacturing facility.
Compensation
$80,300.00 - $131,300.00
Responsibilities
Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management
Requirements
BS/BA in Life Sciences, Chemistry, or Engineering discipline
Provide technical engineering leadership and hands‑on support for commissioning, qualification, validation readiness, and routine GMP manufacturing operations within Drug Product Fill & Finish at Clayton.
Responsibilities
Support commissioning, qualification, and validation activities for GMP Drug Product manufacturing equipment
Coordinate equipment qualification activities from preparation through execution and closeout
Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
Serve as technical system owner for assigned Drug Product manufacturing equipment
Provide day‑to‑day engineering support for aseptic Fill & Finish manufacturing operations
Manufacturing Associate 4, Filling (2nd Shift 3pm to 11:30pm)Fujifilm · Holly Springs, US
Validation Engineer IIIAmneal · Piscataway, US
Quality EngineerSMC Ltd. · Bangalore, India