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Plant Quality Assurance (pqa) Snr Associate, Dublin
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Plant Quality Assurance (pqa) Snr Associate, Dublin
Ireland, Dublin, Dublin,
Modified November 17, 2023
Description
Job Title: Plant Quality Assurance (PQA) Snr Associate Recruiter - Jessica Amaral Duration of Job: 12 months’ Rate - 43-43Euros per hour Join us! There has never been a better time to do your lifes best work! The Role: The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. This is a 24/7 shift role required to support manufacturing operations ( This works by two shift patterns, 7:00 to 19:00 and 19:00 to 7:00). Key Responsibilities: P erform all activities in compliance with safety standards and SOPs. Write, review and approve Standard Operating Procedures in accordance with Policies. Provide Quality support for triage and investigation of all classes of non-conformance (NC) events. Review and approval of deviations for closure ensuring compliance with appropriate documentation. Participates in customer complaint investigations. Provides training and advice to staff in order for them to perform their desired functions. Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions. Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities. Review and approve cGMP records ensuring compliance with appropriate documentation. Support continuous improvement and Operational Excellence initiatives. Any other tasks/projects assigned as per manager’s request. Requirements 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. Excellent written and verbal communication skills. Experience working with dynamic cross-functional teams and proven abilities in decision making. Strong organizational skills, including ability to follow assignments through to completion. Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations. Experience working in aseptic operations, protein formulation, vial and syringe filling. Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues. Benefits Benefit from Independent Solution’s ethical principles. Pre-interview preparation before attending the interview and help to use STAR technology to answer the questions. While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross-functional Life Science team. We offer attractive rates - competitive margins compared to our competitors. Payment on time and in full. We are recognized as approved suppliers to leading key pharmaceutical and medical device companies. You must have the right to work in Ireland for this role. If you have the above skills & and experience, please get in touch with jessica@independentsolutions.ie or apply at Independent solutions provide End-to-end solutions to the life sciences and we are experts in Bio-Tech, Biopharma, and medical sectors. We are the sole source of exceptional Project managers and engineering.
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