Position: QP/QA GMP Manager (IMP)
Overall
Job Purpose:
Manage quality assurance and compliance activities of Branded products on a global level.
Qualified Person for the batch release and certification of Branded products for commercial use in Europe and management of Pharma Branded team. Manage the quality assurance and compliance activities of Investigational Medicinal Products (IMPs) for clinical trials in Europe. You'll be the Qualified Person for the certification of IMPs for clinical use in Europe as delegated by Sponsor. Advice and support on quality aspects of IMPs in non-European clinical trials will also be an important aspect of your role.
Major tasks & responsibilities:
• Responsible for batch release and certification of IMPs and Pharma Branded products as primary Qualified Person; as stipulated in Annex 13 and 16 of Eudralex Vol 4:
• Ensures timely release and certification, to meet commercial planning or clinical trial timelines
• Ensures maintenance of product... specifications in accordance with current Marketing Authorization or Investigational Medicinal Product Dossier
• Review of quality control aspects of API and finished clinical or commercial product
• Review and assessment of associated deviation(s) reports and change control(s) reports
• Review and assessment of corrective and preventive actions.
• Review and assessment of transport conditions associated to commercial or clinical batch importation
• Manage quality assurance and compliance activities of Branded products
• Quality oversight for CMOs. Performing timely communication with both internal and external internal stakeholders according to the requirements of Quality Agreements.
• Review of Product Quality Review reports
• Ensures the comprehensive use of risk management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the marketing authorizations.
• Review, prepare batch documents for QP Batch certification of clinical trial batches, and ensures proper maintenance of product specification files to ensure compliance with IMPDs where applicable.
• Integration of procedures from various systems & processes for clinical trials:
• Maintain compliance to European and local regulatory procedures for the management of clinical trials as per Good Clinical Practices (GCP)
• Support in establishment of local procedures and Company Global Quality Standards (if necessary) for management of clinical trials within Europe
• Management of Quality related deviations (initiation, investigation, closure) related to clinical trials
• Advice and support in all Quality related queries for clinical trials when required
• Liaison between SUN affiliates and local departments to ensure the smooth and timely execution of clinical trials within Europe.
• QMS support:
• Works closely together with the Quality Management System team to support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures.
• Support the maintenance and update of Quality Management System.
• Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authorities
• Business support as required:
• Involvement in new projects
• Knowledge and experience sharing of GxP requirements
• Reviewing the proposal for optimization and process improvements from CMOs for Branded and IMPs
All above as part of the requirements of Regulation No.1252/2014 and Directive
2003/94/EC
Soest Netherlands