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Details
Senior Technical Writer
Reference: | RK3331 | Location: |
Dublin |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Technical Writer
Senior Technical Writer
RK3331
12 Months
Dublin
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Develop/ Update and maintain Operations procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- 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 and management of change controls as required
- 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
- Partner with Operations lead/appropriate SME to ensure updates are correct and aligned with project deliverables/ timelines.
- Perform document trending upon project completion to identify keys issues/mistakes in document processing.
- Support data verification of Operations owned protocols reports and risk assessments.
- Support the 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
- Ensure Non-conformance are triage within the established goal and serve as a deviation owner for minor deviations.
Education and Experience :
- Bachelor’s degree in a Science or Engineering discipline.
- 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.
Packaging Engineer Engineering Supply Chain Quality Control Dublin Microbiology Cork City Clinical Research Laboratory Scientist Scientific PhD Quality Assurance Chemistry Medical Affairs Cork Medical Device Biopharmaceutical Pharma Sales IT Limerick Manufacturing Executive Quality Engineering Diagnostics Supply Chain Academic Allied Healthcare Pharmaceutical Biotechnology Sales and Marketing Sales and Marketing Connected Health Academic Scientist Product Development Engineer Mayo Life Science Validation Engineer Project Manager
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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