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Global Biotechnology company – based in south Dublin, Ireland – looking for Senior Technical writer.
The successful candidate will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.
The Role:
* Develop / Update and maintain Operations procedures in accordance with site and corporate requirements.
* Serve as a document owner.
* 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.
* 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 QA team to ensure that GMP standards are maintained.
* Partner with Operations lead / appropriate SME to ensure updates are correct and aligned with project deliverables / time-lines.
* 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.
Have You:
* 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.
* Strong Project Management and organizational skills.
* Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.
* Escalate issues professionally and in a timely manner.
* Ensures compliance within regulatory environment.
* Demonstrated ability to work independently and deliver right first-time results.
* Experience participating in and leading cross-functional teams.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to [emailprotected]
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