Documentation Specialist

15 hours ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €60,000 - €80,000
Job Overview

This is a key role within our operations team that requires an individual with strong project management and organisational skills. The ideal candidate will also have excellent verbal and written communication skills.

The successful candidate will be responsible for developing and maintaining operational procedures, serving as a document owner and assisting in the generation of training materials.

  • Develop/Update and maintain Operations procedures in accordance with site and corporate requirements.
  • 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.

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.

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 organisation.
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage.

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