Position Summary
The Senior Specialist, Quality Distribution is a key member of the Quality Distribution Team who are responsible for the quality oversight of the distribution of Alexion products world-wide. The position ensures product shipments are managed in compliance with GDP requirements and applicable Alexion procedures.
The Senior Specialist, Quality Distribution works closely with the Alexion Global Supply Chain Team and is the primary Quality technical contact point with external distribution partners
(Distributors & Carriers).
Principal Responsibilities
1. Responsible for Quality oversight of temperature controlled product activities in all markets in accordance with local and international requirements and Alexion planning schedules; insure products shipments are handled in accordance with GDP’s requirements
2. Assess temperature controlled shipments and provides corresponding quality decision on product.
3. Act as primary Quality technical contact point with distribution partners.
4. Provide guidance, drive and monitor Quality issues related to temperature controlled products and GDP to resolution within the company and with external parties
5. Review documentation including change controls, deviations, validation documentation, SOPs and specifications. Ensure documentation processes are followed to ensure appropriate management and notification to internal and external (E-room) collaborators.
6. Ensure Quality Agreement with Alexion’s distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors
7. Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors
8. Support the preparation of Health Authorities inspections and provide support for regulatory submissions
Qualifications
9. Minimum of 5 years quality experience in a HPRA/FDA/EU &/or GMP/GDP regulated environment
10. Thorough knowledge of temperature controlled product activities
11. Thorough knowledge of cGMPs/GDPs and global regulatory requirements
12. International exposure in positions interacting with and influencing site operations
13. Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
14. Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
15. Good verbal and written communication skills with well-structured communication and ability to present to various audience levels
16. Previous experience leading inspection readiness and supporting multiple, global regulatory inspections.
Education
17. Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
Date Posted
25-Oct-2024
Closing Date
30-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.