Cache of job #13721385

Job Title

Quality Officer

Employer

Hartley People

Location

Waterford, Wexford, Kilkenny

Description

Hartley People have an exciting opportunity for an Quality Officer for a 12 month contract on behalf of our client based in Waterford. The Role: Routine Product Release/Clinical release: To conduct documentation review of entire batch package in line with regulatory requirements, including where applicable, Deviation, OOS and Stability investigation reports. New Product/Validation: Quality support for introduction of new products, equipment and facilities. Partners with R&D and other cross functional partners to ensure the proper application of design controls and risk management. To generate, review and conduct process, packing, cleaning and temperature mapping validation reports in line with current regulations and industry best practice, within required timelines. Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA’s and key variances) and take corrective action as required ensuring continuous improvement in accordance with Company Continuous Improvement Process. To ensure that all work carried out is in Compliance with the required standards conforming to company, cGMP, cGLP’s, SOP’s, regulatory regulations and guidelines, H&S and environmental guidelines. Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements. Review, trending and assistance in managing of deviation reduction in conjunction with relevant departments. Generation and approval of Technical Agreements. To deliver Customer Service (both internal and external) through agreed timelines in accordance with quality standards and cost control. Participate in CI activities / projects / root cause analysis and solution implementation to enhance the product value streams. To conduct simulated IMB/FDA systems inspections to ensure the company is at all times ready for audit. Conduct audits of Suppliers where necessary and provide assistance to the Vendor Certification Programme. The Person: Qualification in a Science Discipline and work experience in Pharmaceutical/Medical Device with two year’s experience in a QA environment. In depth knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits. Understanding of Production and Laboratory systems to effect decisions consistent with business needs. Experience of combination devices/pharmaceuticals manufacturing is preferred. An understanding of internal/external customer requirements and an ability to respond promptly to needs. Ability to participate in day to day activities and projects by providing Quality support across the entire Value Stream. Ability to work on own initiative to meet and exceed business objectives. Experience with Trackwise, SAP and strong report writing skills. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Pairic on 051-878813 or email your CV in a word document to pairic@hartleypeople.com.

Date Added

2531 days ago

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