Orion Group

Senior QA Associate 30416 (BB-25349)

Found in: Neuvoo Irlanda

Description:
Orion Group Life Sciences have an exciting opportunity for a Senior QA Associate for our Multinational Biotechnology client based in the South of Dublin area on an initial 12-month contract with the potential to extend.Job PurposeThe Quality Assurance (QA) Snr Associate will typically report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve as Quality point of contact for Plant Quality Assurance Inspection Operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. A variety of shift patterns may be required to support operations, primarily 24/7 shift. Main Responsibilities of the rolePerform all activities in compliance with the Client's safety standards and SOPsObserve and provide real-time Quality oversight and support for Inspection Operations.Perform Visual AQL audits as part of the inspection process.Perform QA Reserve Sample Inspections as part of the Annual Reserve Inspection program and in support of Customer Complaint investigations.Provide Quality support for triage and investigation of all classes of deviation eventsReview and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievableReview/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.Provides training and advice to staff in order for them to perform their desired functions.Write, review and approve Standard Operating Procedures in accordance with the Client's Policies.Support continuous improvement and Operational Excellence initiativesAny other tasks/projects assigned as per manager's request.Desired Experience and Background of the successful candidateBasic Qualifications & Experience:University degree. Engineering or Science related discipline preferred.Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.Preferred Qualifications & Experience:Excellent written and verbal communication skillsExperience working with dynamic cross-functional teams and proven abilities in decision makingStrong organizational skills, including ability to follow assignments through to completionDemonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigationsKnowledge of applicable Regulatory requirements, and ability to evaluate compliance issuesOperational Excellence experienceFor more information on this role, call Ian Towler on +353 (0) (phone number removed) or email (url removed) for a completely confidential chat about this role and other opportunities using the reference number: (phone number removed)Our role in supporting diversity and inclusionAs an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment

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location_onDublin, Ireland

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