Job Type: Contract
Job ID: JO-1901-12380
Consultant: Karen McHugh
Are you a Technical Writer with significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.?
If you would like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development, send your CV to firstname.lastname@example.org?
Technical Writer - Amgen - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
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 organisation.
Exceptional recent graduates with graduates, with excellent written skills and microsoft word considered.
Contract rate of €20 - €30 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or call +353-1-7978720
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