Technical Writer

3 weeks ago

Dublin, Ireland Ascend Project Management Full time

Client Services Manager | Life Science & EngineeringAscend PM are hiring a Technical Writer to join our clients team, a multinational biopharmaceutical company based in Dublin.This is a great Contract opportunity to join a growing team.Initially 12 Month Contract with view to extend.Contact or email CV to to find out moreOverview:This position involves developing, reviewing, and maintaining technical documentation that supports Engineering, Manufacturing, and Inspection operations, while ensuring compliance with GMP standards.Key Responsibilities:Develop, review, and update Standard Operating Procedures (SOPs) and other supporting technical documentation for Engineering, Manufacturing, and Inspection.Manage, own and oversee change controls across functional areas.Collaborate with Manufacturing, Inspection, and Engineering teams to coordinate change controls and documentation updates in a timely and effective manner.Develop and execute protocols within Manufacturing and Inspection in support of change controls.Lead investigations, manage deviations, and coordinate troubleshooting efforts with subject matter experts (SMEs).Participate in projects focused on continuous process improvement and issue resolution.Work closely with Quality Assurance to ensure that all processes and documentation comply with current Good Manufacturing Practices (GMP).Support the Production Support team to minimize document turnaround times.Utilize approved software systems and standard procedures to compile, maintain, and track documentation, including SOPs and related records.Provide technical and administrative support to cross-functional teams, including document preparation, data collation, and tracking of SOPs.Take ownership of deviation management and ensure timely documentation and resolution.Qualifications:Experience favorable in Aseptic practices, Upstream and downstream manufacturing, Engineering, Validation, and Aseptic Processing within the biotechnology or pharmaceutical sectorsSeniority level:Mid-Senior levelEmployment type:ContractJob function:OtherIndustries:Pharmaceutical Manufacturing#J-*****-Ljbffr

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