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/ 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.
• 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-conformance are triage within the established goal and serve as a deviation owner for minor deviations.

• 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