Senior Technical Writer
Hybrid
RK5538
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



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.




Key Responsibilities:

• Develop, update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in the 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 key issues/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 & engineering teams in the preparation of documentation, collation of data and tracking of SOPs.
• Ensure non-conformances are triaged within the established goal and serve as a deviation owner for minor deviations.
• Own corrective/preventive actions and effectiveness verification.

• Bachelor’s degree in a Science or Engineering discipline.
• 3+ years of experience in Chemistry, Microbiology, Engineering or Validation gained within a biotech, pharma or healthcare organisation.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is an advantage.
• Strong project management and organisational skills, including the ability to follow assignments through to completion.