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
Educated to degree level or equivalent.
Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization