Technical Writer

PE Global is currently recruiting for a Technical Writer for a leading multi-national Pharma client based in South Co Dublin..
This is a hybrid position.
Role:
An exciting opportunity has opened in the ADL Manufacturing Support team for a Technical Writer. In this role, you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.
Responsibilities:
• Develop/ 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/Engineering regarding documentation changes in an effective and timely manner
• Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
• Involvement in projects as part of continuous process improvement and / or troubleshooting
• Ownership and management of change controls as required
• Issuance and updates of paper batch records in line with production schedule
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
• Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
• Perform document trending upon project completion to identify keys issues/mistakes in document processing.
• Support data verification of Operations owned protocols reports and risk assessments
• Strong Project Management and organizational skills, including ability to follow assignments through to completion
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
Requirements:
• Bachelor’s degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage

Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***