Cache of job #14130879

Job Title

Snr QA Specialist

Employer

CareerWise Recruitment

Location

Dublin

Description

A Senior QA Specialist is required by CareerWise Recruitment for our Biotech client in South County Dublin. Please contact Diarmuid Buckley for full details. THE ROLE: * Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations. * Quality review and approval of Process Development and Validation documentation. * Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents. * Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations. * Provide Quality direction and input at Change Control Review Board and assume QA oversight of change control and Deviation/CAPA records. * Participates in customer complaint investigations. * Provides training and advice to staff in order for them to perform their desired functions. REQUIREMENTS: * Hons Degree. Science or Engineering related discipline preferred. * Understanding of principles of Validation and New Product Introduction. * Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas. * Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations. * Experience working in aseptic operations, protein formulation, vial and syringe filling preferred. Please call Diarmuid Buckley for further information on 021 4355432 or email: dbuckley@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Date Added

1169 days ago

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