Technical Writer
An amazing opportunity has arisen for a Technical Writer in a manufacturing support team on a hybrid basis. This is a hybrid position and you will be responsible for owning and managing change controls critical to the site development.
Responsibilities:
* 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.
* Own corrective /preventative actions and effectiveness verification.
* Support execution of C&Q, characterisation, functional testing protocols as required by project. NOTE: This may require flexible working hours.
Preferred:
* 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
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on
or send your CV to
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