Job Description
This role is in the Quality CMO oversight team is accountable for oversight of Biologics product manufactured at CMOs.
The scope includes Drug Substance, Drug Product and Finished Drug Product CMOs
This QA team will work with our external CMO partners and internal Quality teams within this department. This function works closely with External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.
Accountabilities
The QA Specialist is the Quality contact for CMO(s) maintaining oversight at those CMOs for Quality related topics.
Is the Quality representative on the External Supply team and works collaboratively with this cross-functional team and CMO to facilitate the supply of product to our patients according to SOPs and GMP standards.
Prepares for and attends relevant CMO governance meetings and internal meetings.
Resolves quality-related topics and escalates where further input is required.
Is the Quality contact/approver for Quality documents, for example, change controls, deviations, CAPAs, validation documents related to CMOs and is the Quality approver for CTL documents.
Maintaining and improving CMO quality metrics that incorporate continuous improvement methodologies.
Supports internal audits and Health Authority inspections as required.
Education, Behavioural Competencies and Skills:
6 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
Thorough understanding of quality systems and cGMPs.
Experience conducting audits and/or involvement in preparation for Health Authority inspections.
Interpersonal skills and communication skills to interact with CMO partners and other functions.
Must be able to prioritise in a busy environment.
Must be able to travel -approx. 20% (domestic and international)
Must be fluent in English
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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