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
- Educated to degree level or equivalent.
- Experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.