QA Manufacturing Specialist
Pe Global
Dublin
PE Global is currently recruiting for a Manufacturing Specialist for a Client site in Dublin: The Manufacturing Specialist will be primarily responsible for: • Develop, review and update production Standard Operating Procedures. • Develop, review and update master/generic batch records, bills of materials etc. • Develop, review and update Product Quality Risk Assessments. The Manufacturing Specialist will also function as the Manufacturing point of contact on New Product Introduction (NPI) Projects and be responsible for: • Partnering with key functional groups to drive strategy definition for risk assessments, characterization, validation, regulatory, and filing milestones. • Lead Product Team meetings. • Ensure compliance with project milestones such as conformance batches manufacturing, regulatory submissions, and product launches. • Hold people to account for delivery and behaviors within Product team. • Function as the site interface between the Product Delivery Teams (PDT’s), and Senior Management. • Author, Reviewing and Approving new training materials. • Develop, review and update Protocols for manufacturing activities. • Documentation and approval of protocol deviations for manufacturing activities. • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing. • Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences. • Liaise with Process Development regarding documentation changes in an effective and timely manner. • Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP’s for submission to the Product Lead. • Provide technical and clerical support to the production team in the preparation of documentation, collation of data. • Own and lead change controls as required by the NPI Project Team. Qualifications: Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR. Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR. 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment * Detailed technical understanding of fill/finish operations. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Strong technical writing and presentation skills. Ability to be flexible and manage change. Ability to communicate and collaborate with technical and management staff. Project Management experience. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.
2163 days ago