PE Global is currently recruiting for QC Associate Specialist for a leading multi-national Pharma client based in Carlow.
This is a contract position.
Role:
You will support all aspects of New Material Introduction process and associated supplier changes ensuring effective interaction with other departments/global teams on matters related to new material introduction and associated qualification as well as support selection and management of external testing Laboratories ensuring all outsourced methods are validated and suitable for the product/material required.
Responsibilities:
Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP
Facilitate and drive effective communication to ensure success through representation of QC team on tier meetings
Support all aspects of New Material Introduction process ensuring effective interaction with other departments/global teams/ external contract testing labs on matters related to new material introduction, supplier changes and associated qualification
Participate and support Internal/External Investigations
Coordinate the creation/ update to Quality standards for raw materials and components at Carlow.
Complete impact assessments for change controls related to Carlow processes
Coordinate any efficiency/ increased Lab capability projects as detailed by Quality Control Manager
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility
Coordination, ownership, and author as required for Annual Product Review
Participate in Quality Risk Management
Requirements:
Bachelor's degree or higher preferred; ideally in Chemistry, analytical chemistry or a related Science discipline or relevant experience
2-4 years of experience in a cGMP laboratory environments
Knowledge of or previous experience in New Material Introduction process
Proficiency in Microsoft Office and job related computer applications required
Good communication, interpersonal skills and ability to work across teams
Demonstrated ability to drive the completion of tasks
Demonstrated ability to solve problems/perform investigations
Method validation and method transfer experience would be advantage
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to ******
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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