Technical Writer

Job Title: Technical Writer

Summary:

An exciting opportunity has opened in the Manufacturing Support team for a Technical Writer. In this role you will be responsible for owning and managing change controls critical to site development and managing the operational documentation updates as required by each project.

Requirements

Primary 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 nonconformances & 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 Nonconformance 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.

Knowledge/Skills:

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 firsttime results under minimal direction

Experience participating in and leading crossfunctional teams

Experience in managing multiple competing priorities in a fastpaced environment

Relevant 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

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