Technical Writer
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Job Type | Contractor |
Area | Dublin, Ireland |
Sector | EngineeringQualityOperations & Manufacturing |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | #2044 |
Job Views | 312 |
- Description
- We are seeking applications for a Technical Writer on behalf of our Client who are a pioneer in the Biotechnology industry. This role will be based in their aseptic drug product operations facility in Dublin.
Why you should apply:
State of the art working facilities, including Next Generation office areas and on-site gym.
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
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, deviations & 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 minor deviations as required
What you need to apply:
Educated to degree level or equivalent.
Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.