Website Asset Recruitment
Senior Quality Specialist
Division: Pharmaceutical Development Quality, R&D
Our client is a fast-growing biopharmaceutical group specializing in the development of innovative medicines in oncology, neuroscience and rare diseases.
Within the Global Pharmaceutical Development organization (3 European sites), you will actively contribute to the strategy of becoming a center of excellence in the development of toxins, small molecules and medical devices and strategical partner in the life cycle management of the established products.
Drug substance batches for clinical trials
• Check or approve the documents needed to manufacture and release batches such as the master batch records, related documents (instructions, forms, development protocol/report, etc.) clinical batches.
• Approve starting materials and drug substance by ensuring the quality of products for clinical trials
• Manage quality events (such as deviations, out of specification results, complaint) ensuring the appropriate investigation and root cause analysis. Review and approve associated CAPA plan. Ensure an effective implementation of corrective and preventive actions in timely manner.
• Perform batch records review and approval ensure product and production process and testing compliance with regulatory requirements.
• Manage Quality activities and relationships with CDMOs and service providers. Manage their upgrading on operational quality aspects,
• Contribute to Product Specification file and Supply Chain flow diagram authoring
Stability studies support for projects development
• Review stability protocol and report approval by SYR)
• Approve the documents needed to manufacture stability batches such as the master batch records, related documents (instructions, forms, development protocol/report, etc.) clinical batches.
• Manage quality events (such as deviations, out of specification or out of trend results, complaint) ensuring the appropriate investigation and root cause analysis. Review and approve associated CAPA plan. Ensure an effective implementation of corrective and preventive actions in timely manner.
Analytical Quality Support & Qualification / Validation
• Approve product specifications
• Approve Reference standards qualification/characterization report
• Approve Reference standards stability protocols and report
• Approve equipment qualification report
Quality Systems & Support for Projects Development
• Approve project development product documentation,
• Contribute to identify quality processes and related documentation needs ensuring the appropriate interface within Dublin Technical Operations QMS and global Pharm Dev QMS.
• Ensure appropriate change management (analytical and/or chemical): monitoring, follow-up, records in Quality system, impact evaluation on the drug substance and communicate to Drug Product Quality team
• Ensure the local deployment and sustainability of the global Pharm dev Quality Management System
• Monitor Quality performance of APID organization: data collection, targets definition, best practices promotion, improvement initiatives support, and appropriate reporting to Global Pharm Dev Quality.
• Define and maintain the audit universe applicable to APID activities in conjunction with the Pharm Dev
Quality service provider manager
• Contribute to regulatory authority inspections
• Contribute to review the batch documentation against approved IMPD/IND
Qualifications, Skills & Expérience:
• Bachelor’s Degree or equivalent in a scientific or technical discipline of relevance
• 5+ years’ direct experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and Manufacturing Operations for Drug substance and/or Drug product
• Solid expertise in Drug substance manufacturing and /or development
• Solid working knowledge of regulatory requirements (FDA, ICH, EMA) including GxP principles
• Demonstrated experience with third party manufacturing contractors is an asset
• In-depth understanding of drug substance pharmaceutical manufacturing (cGMP) and laboratory work
• In-Depth knowledge of quality systems and their maintenance/implementation in API sites