Quality Officer
Matrix Recruitment
Waterford
Matrix Recruitment Group is currently seeking a Quality Officer to be based in Waterford . As the Quality Officer you will work for our client, a Pharmaceutical company, in a contract job. As a Quality Officer you will be expected to ensure the organization is in compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and temperature mapping validation of all areas against the regulatory standards. Key Responsibilities. Routine Product Release/Clinical release: To conduct documentation review of entire batch package in line with regulatory requirements. 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. Quality Systems Development: To develop and improve quality systems by identifying areas for improvement. 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. Conduct audits of Suppliers where necessary and provide assistance to the Vendor Certification Programme. Essential Criteria. Qualification in Engineering/Science Discipline and work experience in Pharmaceutical/Medical Device with two years’ 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. Ability to participate in day to day activities and projects by providing Quality support. Inhalations and MDPI experience would be beneficial. Our highly experienced consultants are here to help find the right job for you. Apply now or get in touch with Cathal regarding this role on 059 9139070 for more information. Matrix Recruitment Group is committed to providing a professional service where all CV's are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent. This job originally appeared on RecruitIreland.com.
2583 days ago