Senior QA Specialist
|Job Title:||Senior QA Specialist|
|Job Published:||about 2 years ago|
Would you like to work for one of the market leaders within the pharmaceutical sector? I have a fantastic opportunity with one of the market leaders offering 9 month contracts (immediate start).
This position is responsible for the management & control of EU contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP.
Responsible for QA oversight of CMOs, Printers, Artwork house, Suppliers, QC Labs (as assigned)
Responsible for the compliant day to day management of CMOs, Printers, Artwork house, Suppliers, QC Labs (as assigned).
Leading meetings with external parties and representing in a professional manner.
Attendance at all weekly/ monthly and quarterly CMO meetings.
Escalation and resolution of all quality related issues.
QA support and approval of all CMO/ documentation.
Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible to escalate trends identified as a result of such reviews / reports.
QA contact for all associated CMO/ quality systems e.g. deviations, change controls.
QA representation on projects.
Leading audits (external)
Support Internal and regulatory agency inspections.
Development of quality improvement plans and continuous improvement at CMO?s and within the CMO management group.
Generation / review of CMO TQA?s to ensure agreements are current and within date.
Review 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
Minimum Bachelor?s degree in pharmacy, chemistry, biology or a related discipline.
5-8 years? experience working in a QA role in the pharmaceutical industry.
Thorough understanding of quality systems, cGMPs, GDPs.
Experience with Aseptic/ Sterile Processing/Tableting
Excellent interpersonal skills and professional skills
Must be flexible and comfortable with ambiguity in a ?startup? environment
Must be able to prioritize and multitask in an environment with changing priorities.
Must be able to travel up to 15 %
Experience working with multiple sites/ locations
Experience working with contract manufacturing
Experience interfacing with regulatory bodies or working on regulatory submissions
Ability to work during business hours but be flexible to cover US business hours.
For further information on this QA Specialist 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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