Purpose
An exciting opportunity has opened in the Manufacturing Support team for a Technical Writer. This is a 12-month contract with a view to extension, and it's a hybrid position.
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 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.
Requirements
* 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 (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 under minimal direction.
* Experience participating in and leading cross-functional teams.
* Experience in managing multiple, competing priorities in a fast-paced environment.
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 healthcare organization.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage.