QA Specialist (Tech Support Team)

CAREERWISE RECRUITMENT

DUBLIN

QA TECHNICAL SUPPORT SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in South Dublin, initial 12 month contract on offer. The QA TECHNICAL SUPPORT SPECIALIST 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 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 pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems. * 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.

1484 days ago