Bioprocess Specialist

Details of the offer

PE Global is currently recruiting for a Quality Control Specialist for a leading multi-national Pharma Healthcare client based in Co Carlow. This is an 11 month contract. Role: You will support all aspects of the 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 the QC team in tier meetings. Support all aspects of the 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 the 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: 2-4 years of experience in cGMP laboratory environments. Knowledge of or previous experience in the New Material Introduction process. Bachelor's degree or higher preferred; ideally in Chemistry, analytical chemistry, or a related Science discipline or relevant experience. Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up-to-date CV to ******.

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Nominal Salary: To be agreed

Job Function:

Requirements

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