QA Senior Associate, External Quality OperationsLocation Cork, Ireland Workstyle Hybrid Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients
Senior QA Associate External Quality - Shanbally
Closing date: 15 September 2023
The QA Senior Associate reports to the QA Ops Manager in External Quality, and is
responsible for establishing, implementing and maintaining quality systems, providing quality
oversight of CMO’s and supporting the Quality Team.
• Assist with the quality oversight of the supply chain, manufacture and packaging of BioMarin products in various Contract Manufacturing Organizations.
• Manage and co-ordinate QA CMO batch record review for CMO manufacturing batch records.
• Manage lot release activities, and the communication of lot release schedules to Supply Chain Planning and CMO.
• Review of Manufacturing/Packaging batch records and Quality Control records prior to recommending release of batch.
• Review and approve documentation such as, standard operating procedures (SOP’s), specifications, master batch records, protocols, reports and Trackwise records.
• Review deviation and investigation reports to ensure that root causes were identified and appropriate corrective actions have been implemented.
• Assist with periodic audits and review of contract manufacturers to ensure compliance with GMP’s and other regulatory requirements.
• Assist with regulatory inspections
• Artwork approval
• Recalls and/or notification of events to regulatory agencies
• Train, develop and mentor individuals within the team
• Collaboration with BPI QALR; BPI QA CMO and SBY QA as applicable to job function
• Participate in and/or support cross-functional CMO teams and associated initiatives.
• Participate in and implement initiatives that add value to QA CMO operations.
• Develop and maintain internal and external relationships and ensure customer satisfaction through effective communications.
• Support the following activities, as appropriate:
• Processing external complaints
• Quality deviations and Laboratory Investigations
• Change Controls
• New or updates to relevant quality agreements
• Validation activities
• Perform Audits internal and external
• Annual Product Reviews
• Bachelor of Sciences (BSc) degree, or higher, in a technical discipline
(physical, engineering, chemical or biological sciences) is required.
• A minimum of 5-10 years’ experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
• Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations.
• Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
• Ability to speak, present data, and defend approaches in front of audiences and inspectors.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
• Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO’s.
• Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.