Description: We are recruiting for a Tech Writer on behalf of a leading biotech company in Dublin South. This is an initial 12-month contract role.
Job Summary: The ADL Manufacturing Support team has an exciting opportunity for a Technical Writer. You will own and manage change controls critical to site development, managing operational documentation updates as required by each project.
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 provide 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 key 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 triaged 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.
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
* Strong Project Management and organizational skills, including ability to follow assignments through to completion
* Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (investigations, procedures, change controls) and good Presentation skills
* Escalate issues professionally and in a timely manner
* Ensure compliance within regulatory environment
* Demonstrated ability to work independently and deliver right first-time results under minimal direction
* Experience participating in and leading cross-functional teams
* Experience in managing multiple, competing priorities in a fast-paced environment