This is a contract based role for an Associate Quality Control Specialist as part of the Incoming Quality team reporting to the Quality Control Manager.
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.
The role: 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 the site.
Complete impact assessments for change controls related to site 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 Skills & Experience: 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 The Next Step for you: Should this position be of interest to you please forward your CV to Barry O'Mahony from Next Generation Recruitment or alternatively call on the main line on Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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Skills: QC Analyst Carlow Pharma