Cache of job #14084963

Job Title

QA Technical Support (12m, Dublin)






QA TECHNICAL SUPPORT SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in South County Dublin, initial 12 month contract on offer. The QA TECHNICAL SUPPORT SPECIALIST position is a senior position within the QA function which will typically report to a QA Senior Manager. They will 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. THE ROLE: * Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents / Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents / Review of executed validation documents and reports. * 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 regulatory expectations. * Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. * Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. * Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. * Perform all activities in compliance with safety standards and SOPs. REQUIREMENTS: * University degree. Science or Engineering related discipline preferred. * Relevant experience (5yrs ) working in the Medical Device, pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. * Understanding of principles of Validation and New Product Introduction. * Experience in change control, non-conformance, corrective and preventative actions, and validation practices. * Ability to operate across functional boundaries, both internal and external. * Ability to work independently and remotely with minimum direct supervision. * Critical thinking skills. * Strong organisational, communication, coordination, and meeting facilitation skills. * Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. * Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Please call Conor Twomey today for further information on 021 4297422 or email: 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

231 days ago