Website Ref: TPM03890
A biotech company in South Dublin is looking for a Technical Writer to join their team. The successful candidate will develop, review and update engineering, manufacturing and inspection Standard Operating Procedures and liaise with Manufacturing / Inspection / Engineering regarding documentation changes in an effective and timely manner.
- 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.
Qualifications & Experience:
- Educated to degree level or equivalent.
- Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.
- 5+ years experience required.
To apply for this job email your details to firstname.lastname@example.org.