Responsible for Quality Assurance activities that directly support execution of Quality Management of Suppliers responsible for the intake of Product Quality Complaints on behalf of Affiliate Quality. This includes: Quality System oversight and/or performance of: audits, change control, product quality complaint and deviation investigations, issue management and escalation, Agreements (establishment and maintenance) between the client and External Suppliers. The preparation and submission of Supplier Quality Assessments, Regulatory Agency interactions (prep and management of inspections at external suppliers and Client sites when external suppliers are assessed).
Responsibilities:
- Conducts vendor oversight of all case intake and processing activities and PQC intake quality including analysis and reporting of trends in quality measures
- Coordinates change for significant changes or Good Manufacturing Practice requirement changes affecting Global External Sourcing supplier
- Maintains a high level of understanding of relevant processes and quality systems
- Collaborates with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality system
- Accountable for providing Quality Assurance Technical support for cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions
- Collaborates with, and influence, assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external Quality Assurance practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to Global External Sourcing/AstraZeneca site leaders
- Collaborates in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility
- Ensures compliance with global and local procedural documents and local implementation of Corporate, GMP/GDP and Quality objectives, policies, processes and procedures. Leads continuous improvement of the GMP/GDP and Complaint intake process
Qualifications:
* Bachelor's degree in science or technical area
* Considerable industry experience across a wide range of international Operations or Research and Development functions
* Proficiency in global regulatory requirements for PQC handling
* Proven experience working on critical acute problems in multifunctional, international senior-level teams
* Experience working in GMP/GDP in an above-country role and/or with vendors
* Maintains an up to date knowledge of international product quality complaint regulations.
* Verbal and written English skills are mandatory
* Experience in managing/supporting inspections
