Batch Record Reviewer Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Primary responsibility for all medical device product release activities to ensure that products are manufactured and released in accordance with regulatory requirements and the principles and guidelines of current Good Manufacturing Practices and Good Documentation Practices. The Batch Record Review Specialist will provide technical quality leadership and support for Takeda's on- market medical device and combination products. Work collaboratively with internal Quality and cross-functional colleagues to ensure Takeda's medical devices and combination products comply with FDA 21 CFR requirements and international standards (e.g., FDA, ISO, AAMI, ANSI).

• Perform in process and final release of medical device products from contract manufacturing organizations (CMOs) for E.U. and international markets including manufacturing, inspection, packaging and labeling batch records to ensure compliance. Generation of associated product release certificates, archiving of electronic and hard copy batch documentation.
• Ensure all appropriate CMO batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products in a timely manner. Communicates with cross functional team and CMOs to align on product release timelines and resolve batch record issues.
• Approve product certification documents for Takeda device and combination product components.
• Creates and updates quality agreements, processing new supplier requests and supplier change notifications. Assists with supplier quality related activities during transition of responsibilities from SQM to Device Quality.
• Perform batch record searches in support of complaint investigations.
• Support new product launches by assisting with the creating of a release process.
• Report quality system metrics relating to medical device product release activities as required
• Assess applicability of current standard operating procedures, device master records and product specifications.
• Assist with device quality continuous improvement projects.

• BS in Regulatory affairs or equivalent technical discipline required, and advanced degree preferred
• 3+ years of device and/or combination product experience within a medical device or biopharmaceutical organization
• Extensive knowledge of E.U., U.S. and international drugs and medical device regulations and standards including FDA 21 Code of Federal Regulations (CFRs) Part 820, 803, 211, 210, E.U. IVD and Medical device regulations, ISO 13485, ISO 14971.
• Experience with batch release process and excursions generated during GMP activities such as deviations, non-conformances (NCR), out of specification (OOS) investigations and CAPA
• Experience in leading, conducting, hosting medical device quality system audits (per ISO 13485 and 21 CFR 820) in addition to Medical device risk assessment per ISO 14971 and associated tools -FMEA, FMECA
• Experience in preparing and reviewing materials/deliverables for device submissions to Regulatory Authorities i.e. FDA, European Bodies
• Prior experience in a product release role
• Experience in providing quality support to on-market/commercialized products
• Experience in working with external suppliers &/or contract manufacturers

Desired:

• Experience with statistical and six sigma methods required, and Green/Black Belt preferred
• Experience with drug delivery injection systems preferred
• Experience with SAP, Track wise or similar systems preferred

• Experience in leading quality projects/activities required, and specific experience in leading remediation projects preferred