The Quality Specialist will support QRM and compliance activities as required for the KCDM project, in collaboration with the project team. The Successful candidate will ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.
•Lead the QRM activities required for the NPI capital projects.
•Act as QRM facilitator and Risk lead for project QRAs.
•Schedule the completion of project QRAs and track to completion including trackingto closure associated QRM CAPAs.
•Ensure linkage from the output of the QRAs to the Commissioning, Qualification andValidation strategies.
•Support the facilitation of site QRAs which are required for update as a result of NPI.
•Present QRAs for concurrence at Site QRM Council.
•Support for related Compliance deliverables in support of audits and inspectionreadiness.
•Support for Change Management activities.
•Provide compliance contribution to project teams and leads small projects.
•Understands and applies regulatory / compliance requirements to their role togetherwith remaining current on upcoming company and regulatory expectations andcompliance changes/challenges.
Minimum Qualifications and Experience:
Purpose: Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC...Apply For This Job
Purpose: The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. This involves testing...Apply For This Job
Purpose: An exciting opportunity has come for a Validation Engineer to join the Carlow Commercialisation team to transition from a...Apply For This Job
Responsibilities Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition....Apply For This Job
Purpose: The PAT & Labs engineer will be responsible for delivery of Process Analytical Technologies and Lab equipment scope on...Apply For This Job
Purpose: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company...Apply For This Job