Job Title: Technical Writer (Senior) A32193
Our client is a Multinational Biopharmaceutical company with more than 20,000 employees worldwide and approximately 500 workers in its D n Laoghaire (co. Dublin) facility, which is a 37,000-square-metre aseptic operations facility with freeze-dry product (lyophilization) and liquid vial-filling capabilities.
Its Irish site specializes in secondary manufacturing activities formulation, fill, and packaging, and also includes a bioprocessing suite and laboratories. The local team is currently engaged in one of the largest and fastest technology transfer programs in the company s history. Make a difference in the lives of others, working at the forefront of biotechnology with the top minds in the field.
Duration of Job: 12 months
- 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
Requirements
- Educated to degree level or equivalent.
- significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation
*** No Visa Processing ***
Benefits
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates - competitive margins compared to our competitors
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have a continuous supply of High-Value Projects
We work for you!
Educated to degree level or equivalent. significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation *** No Visa Processing ***