QA Specialist

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA’s. Acts independently to determine methods and procedures on new assignments and provides guidance to lower-level personnel. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

YOU WILL BE RESPONSIBLE FOR:

Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
Provides oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
Works closely to build relationships with contract manufacturers quality personnel
Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
Responsible for reviewing contractor documents i.e. Batch records, deviations and change controls to ensure that they comply with Alexion procedures and meet Alexion standards
Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations
Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
Develop and issue quality metrics pertaining to the process quality activities
Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Represents Quality Assurance to guide various projects and technical meetings, as needed
Responsible for documenting and reporting compliance issues to management
Any other duties as required by management.