QA Specialist

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.

You will need to have:

Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment

Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing. Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry

Experience working with contract manufacturing organisations

Ability to provide project leadership and guide successful completion of Quality projects

Excellent written and verbal communication and negotiating skills

Risk assessment and risk management

Ability to exercise judgment with defined procedures and practices to determine appropriate action

Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment

Ability to monitor and report on assigned tasks, goals, and objectives.

We would prefer for you to have:

• Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.