TECH WRITER required by CareerWise Recruitment for our multinational BioTech client in South County Dublin, initial 12 month contract on offer.
The TECH WRITER will develop, review and update engineering, manufacturing, & inspection Standard Operating Procedures.
Role of this position
- 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.
Please call Conor Twomey today for further information on 021 4297422 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)