QA Specialist, External Quality

This is what you will do:

The QA Specialist for External Quality will be responsible, with management support, for  assisting in the oversight of quality activities associated with drug substance/drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist supports ongoing quality assurance responsibilities in support of Contract Manufacturing quality systems including batch release, Change Control, Deviations and CAPA's.  Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

You will be responsible for:

• Quality Assurance support for Drug Substance, Drug Product and Finished product manufacturing at our contract manufacturing organisations.
• Part of the QA disposition team ensuring batches are released to cGMP and Alexion requirements.
• 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 with internal cross-functional impacted areas, such as External Plant Operations, 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.
• Ensure quality metrics pertaining to the process quality activities are maintained.
• Author, review and approval of QAGs and maintain up to date Quality Agreements with all GxP vendors.
• Reviews and assesses deviations; includes 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
• 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. Demonstrating a clear understanding of production processes, critical parameters, and operatons across multiple areas.

• Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing and understands its implications on own area of work.
• Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry.
• Experience working with contract manufacturing organisations.
• Excellent written and verbal communication and negotiating skills
• Ability to exercise judgment with defined procedures and practices to determine appropriate action. 
• Has the ability to interpret and advise on quality standards to build quality in process, monitor performance and seeks opportunities for continuous improvement.
• Able to look at a variety of data sets with a critical lens and draw out more meaningful insights that are not so obvious.
• 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. Able to look at a variety of data sets with a critical lens and draw out more meaningful insights that are not so obvious.

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.