Senior Technical Writer
RK3331
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.




Duties:

• Develop, review and update manufacturing documentation.
• Ownership of change controls for Manufacturing.
• Liaise with Manufacturing regarding documentation changes in an effective and timely manner, rolling out one point lessons where necessary.
• Maintain awareness and compliance with project timelines.
• Develop protocols for execution in Manufacturing in support of change controls, deviations & troubleshooting investigations with support from relevant SMEs.
• Support execution of protocols as required by project.
• Involvement in projects as part of continuous process improvement and / or troubleshooting,
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
• Support 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, APPXs, TRNQs.
• Provide technical and clerical support to the manufacturing teams in the preparation of documentation, collation of data and tracking of SOPs
• Ownership of minor deviations as required

• Educated to degree level or equivalent.
• Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.