Quality Officer - Pharma

Brightwater

Waterford

A leading Pharma site in Waterford has 2 vacancies in it's Quality team. Ideally you'll be degree qualified with at least 2 years of experience in a similar role within a regulated manufacturing environment. This is a 12 month contract but comes with an attractive salary and full benefits package. You'll be required to ensure compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and validation activities of all areas against the regulatory standards. Responsibilities: 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 and assistance in Laboratory, Complaint, Vendor and Production investigations and reduction of trends in conjunction with relevant departments. Generation and approval of Technical Agreements and Annual Product Reviews in line with requirements. Routine Product Release/Clinical release: To conduct documentation review of batch records in line with regulatory requirements, including where applicable, Deviation, OOS and Stability investigation reports. 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. New Product/Validation: Quality support for introduction of new products, equipment and facilities. Partners with R&D, Operations and other cross functional partners to ensure the proper application of design controls and risk management. To generate, review and conduct process, packing, cleaning, complaint and validation reports in line with current regulations and industry best practice, within required timelines. Support. 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 HPRA/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 successful candidate should possess the following: 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. Ability to work on own initiative to meet and exceed business objectives. Experience with Trackwise, SAP and strong report writing skills. Inhalations and MDPI experience would be beneficial. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2584 days ago