Quality Specialist - NPI
The Quality Specialist is responsible for day-to-day implementation of Quality Systems and infrastructure appropriate for commercial manufacture in compliance with Current Good Manufacturing Practice (GMP) requirements.
The QA Specialist executes Quality requirements for the oversight of contract manufacturer of Products, associated testing, and supply of medical device products ensuring the realisation of industry best practices for GxP.
The Quality Specialist will review and prepare for approval batch records, Deviations, CAPAs, Change Controls, Supplier Notifications. The QA Specialist will also serve as quality approval proxy as needed, and support supplier audit activities with approximately 15% domestic and international travel.
Review and prepare for approval CMO executed manufacturing records for formulation, filling, assembly, and labeling, packaging and shipping operations of products to ensure completeness, accuracy and compliance.
Review and prepare for approval of CMO production and testing procedures, batch records, specifications and validation protocols and reports.
Review and prepare for approval CMO related production deviations, conducting assessment of batch impact and final decision recommendations for batch disposition. Coordinate and lead cross functional teams to perform high level non-conformance investigations, including root cause analysis. Review and approval of CMO related OOS investigations. Authorise resampling, retesting, and determination of batch impact.
Independently resolve discrepancies found during review with CMO Quality team.
Review and approve supplier and CMO change notifications. Author and coordinate applicable changes through the Change Management process as required.
Review various types of documentation to ensure completeness, accuracy, and compliance. This includes SOP revisions, Protocols, Data Sets, Material Specifications, Validation reports.
Contribute to the continuous improvement of Quality review/ release processes.
Support the stability program as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
Collaborate to support approval of Quality Technical agreements for contract manufacturing, testing, holding/ distribution facilities, and raw material suppliers. Facilitate discussions between and CMO Quality organizations to establish responsibilities for Quality related functions
Serve as Quality Approval Proxy for all areas noted above as required (i.e., Deviation, CAPA, Batch Record documentation, Batch Release, etc.).
Assist audit group with scheduling, preparation, and completion of audits for contracted services and material suppliers.
Review and approve technology transfer activities across contract organizations for production and testing. This includes review of CMO validation protocols and reports for equipment, process and test method enhancements
Support regulatory department with any regulatory filings associated with new market authorizations, annual reports and change supplements
Work with translation service providers to conduct translation activities for manufacturing, testing, qualification/ validation activities.
Responsible for identifying defects and have the authority to report device defects at any time.
EDUCATION, EXPERIENCE, SKILLS
BA/BS (preferably in an Applied Science) or equivalent work experience.
Minimum 6 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Medical Device Manufacturing and previous Quality Assurance experience.
Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred.
Candidate must exhibit strong interpersonal and communication skills.
Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
Strong oral and written communication skills.
Ability to work independently and in a team setting with minimal supervision
Ability to make sound decisions regarding compliance-related issues with minimal supervision.
Strong Leadership, high level of personal/departmental accountability and responsibility.
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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