
Senior Documentation Consultant
1 week ago
Documentation Specialist
About the Role:We are seeking a skilled Documentation Specialist to support our manufacturing operations on a hybrid basis. As a Documentation Specialist, you will be responsible for creating and managing technical documentation critical to site development.
Main 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 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.
- 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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