OverviewDirect message the job poster from Berkley GroupTechnical Writer A manufacturing support team hybrid role. Responsible for owning and managing change controls critical to site development.ResponsibilitiesDevelop, update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.Liaise with Manufacturing, Inspection and Engineering regarding documentation changes in an effective and timely manner.Develop protocols for execution in Manufacturing and Inspection to support change controls, non-conformances and troubleshooting investigations with support from relevant SMEs.Participate in projects as part of continuous process improvement and/or troubleshooting.Own and manage change controls as required.Issuance and updates of paper batch records in line with production schedule.Collaborate with Quality Assurance to ensure GMP standards are maintained in line with current OS.Partner with Operations lead and appropriate SMEs to ensure updates are correct and aligned with project deliverables and timelines.Perform document trending after project completion to identify key issues or mistakes in document processing.Support data verification of Operations-owned protocols, reports and risk assessments.Support the production support team in reducing document turnaround times.Use specified software packages and standard procedures; responsible for compiling and maintaining all relevant documentation including SOPs.Provide technical and clerical support to the manufacturing, inspection and engineering teams in the preparation of documentation, data collation and tracking of SOPs.Ensure non-conformances are triaged within established goals and act as a deviation owner for minor deviations.Own corrective and preventative actions and effectiveness verification.Support execution of commissioning and qualification, characterization and functional testing protocols as required by projects. Note: flexible working hours may be required.Preferred:Bachelor's degree in a Science or Engineering discipline.3+ years of experience in Chemistry, Microbiology, Engineering or Validation within a biotech, pharma or healthcare organization.Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is advantageous.ContactBerkley Life Science & Engineering is a specialist consultancy recruiting Life Science and Engineering professionals for organisations throughout Ireland. For more information go to www.berkley-group.comIf you would like to discuss this vacancy or your career options in confidence, please contact David O'Connell at +353 86 126 3871 or send your CV to doconnell@berkley-group.com
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