GDP Commercial Specialist
Hemel Hempstead, GB
Job Purpose
The GDP Commercial Specialist ensures that Recordati’s Quality Management System supports compliant, efficient, and reliable GxP operations across the commercial supply chain. The role strengthens GMP/GDP quality oversight by partnering with internal teams and external stakeholders to maintain high standards, resolve quality issues, and drive continuous improvement. It also contributes to key departmental initiatives that enhance compliance, operational effectiveness, and inspection readiness.
Key Responsibilities
Quality Systems:
- Provide QA support in alignment with Recordati Quality Management System and applicable GMP/GDP regulations
- Establish, review and maintain procedures and quality documents
- Record, assess and manage deviations and distribution complaints within the designated quality system
- Coordinate investigations by engaging with warehouses, 3PLs, distributors, and internal teams to ensure timely and complete data collection and recording
- Verify documents related to returns and approve checklists prior to RP decision-making
- Liaise with third parties to confirm stock receipt, quarantine status, and reconciliation
- Track, manage and close action items and CAPAs as appropriate
- Initiate and manage changes related to warehouses/3PLs, distributors
- Maintain up to date licenses for warehouses/3PLs, distributors
- Review Quality Agreements as required
Key Responsibilities
QA Coordination:
- Provide GDP guidance and support across Recordati commercial and industrial operations
- Act as the QA point of contact for the central warehouse 3PL and other relevant partners
Quality Systems Requirements
- Maintain an understanding of RRD Pharma working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation
Technical/Professional Expertise
- Master’s degree in medical, pharmaceutical or science discipline
- Previous experience (5 years) in a GMP/GDP environment, ideally in Quality Assurance
Required Behaviours and Competencies
- Analytical thinking to manage in advance new legal requirements
- Negotiation and project management skills
- Problem solver
- Fluent in English (business)