Amgen Sr Document Control Associate in Dun Laoghaire, Ireland

The activities performed in the role of Technical Writer include:

  • Develop, review and update Engineering, Manufacturing & Inspection Standard Operating Procedures.

  • 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 of change controls for Manufacturing/Inspection/Engineering

  • 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

  • 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

  • Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs

  • Ownership of Level 1 non-conformances

Basic Qualifications:

  • Educated to degree level or equivalent.

  • Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization