Overview
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.
The ideal candidate will have strong project management and organisational skills while also having excellent verbal and written communication skills.
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.
Qualifications
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-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on +353 86 126 3871 or send your CV to doconnell@berkley-group.com
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