Quality Manager Sterile manufacturing
|Job Title:||Quality Manager Sterile manufacturing|
|Job Published:||about 4 years ago|
The Quality Manager will work in the EU Quality Operations which oversees Qualified Person function, contract manufacturing operations, supply chain operations and supplier quality functions performed. The QA Manager will be responsible for the QA management of EU contract manufacturers, suppliers and test labs as applicable. This position will not have direct reports.
Responsible for QA Oversight of CMOs, Printers, Artwork house, Suppliers, QC Labs.
Responsible for the compliant day to day management of CMOs & resolution of all quality related issues.
Leading meetings with external parties and representing in a professional manner.
Attendance at all weekly/ monthly and quarterly CMO meetings.
Represent management in meetings and cross functional teams.
Responsible for the EU Supplier List.
QA support and management approval of all CMO documentation.
Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible to recommend actions as a result of such reviews / reports.
Management of critical issues and timely resolution, developing solutions to complex problems.
Proactive monitoring the performance of CMOs & suppliers to ensure that they remain in a state of control & implementing necessary improvements.
Leading, reviewing and approval of deviations, change controls which are related to CMO management.
Manager oversight and approval on all applicable quality systems pertaining to CMO management including but not limited to Deviations, Change Controls, CAPAs.
Management of annual vendor assessments
Leading or supporting CMO / Quality projects
Leading audits (external)
Support internal and regulatory agency inspections
Analysis of CMO management processes, development of quality improvement plans and continuous improvement.
Update and compliant management of CMO TQAs to ensure agreements are current and within date.
Review and approval of CMO Annual Product Quality Reviews
Roll out of training on QA procedures
Support validation activities related to CMO?s/ CTL?s as required
Support investigations into complaints
Support product launches activities associated with CMO?s/CTL?s/ Suppliers
Providing escalation, weekly updates, reports and stats to management as required.
Education & Qualification
Project management/ Lean / OE experience
Experience working with multiple sites/ locations
Experience working with contract manufacturing
Experience interfacing with regulatory bodies or working on regulatory submissions
Experience with pre-filled syringes
The position may require up to 15% travel.
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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