Principle quality officer - hurley
Job Title: Principal Quality Officer
Location: Hurley, Berkshire
Rate: Up to £36 per hour dependent on experience
Contract: 12 months
Hours: 37 hours per week (Mon-Fri)
- Reporting to the Global Transportation Quality Leader, the Principal Quality Officer will provide expert support for the development and implementation of a Global Quality Management System and Operations distribution model for commercial pharmaceutical distribution from Global manufacturing plants to network locations.
- The position has the purpose of developing and maintaining systems and Quality Operational decisions that support Transportation Quality Assurance compliance and product continuity of supply.
- You will be an individual contributor to a cross functional team, be a technical expert in both Good Manufacturing and Distribution Practices for Intercompany Operations, lead and support the management vendor assurance activities, complex logistics change management, investigations, and competent authority inspections.
- Key responsibilities include working within a cross functional team and individually, working to support the assessment of existing processes, design of new processes, writing and implementation of written procedures, embedding of new and advanced digital technologies within processes, vendor assurance and management activities, cross functional stakeholder collaboration, negotiation, training, and education.
- You will lead and support the management of Global IO TQA vendor management activities, logistics change controls, resolution of complex failure events and support continual process improvement.
- You will have an advanced theoretical knowledge and practical implementation of the legislative and QMS requirements within the GDP Transportation and GMP Manufacturing space.
- You will ensure competent authority enquiries, inspections, visits, and internal audits are appropriately supported and issues resolved in a timely and robust fashion.
- Management of and continual improvement of assigned quality system elements to ensure full oversight, completion of associated responsibilities and tasks, provision and interrogation of metrics data and associated identified actions.
Training & Education Required:
- MSc or BSc (hons) in scientific field or equivalent (Preferably Biology / Chemistry/ Pharmacy/Life Sciences)
Prior Experience Required:
- Advanced practical experience in pharmaceutical transportation, digital technologies, vaccine manufacturing, and control measures
- Experience in Quality administered systems. Previous use of SAP and Trackwise® QMS providing a significant advantage.
- Comfortable in working across EU and US time zone equally.
Prior Experience Preferred:
- Experience associated with operating within EU and US Transportation Supply Chains, Quality Standards and be considered equivalent to or have been trained and experienced as a Responsible or Qualified Person.
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