Sr Document Control Associate

Category: Manufacturing
Job ID: R-70508
Employment Type: Full time
Location: Ireland – Dublin
Posted Date: February 8, 2019

The activities performed in the role of Technical Writer include:

  • Develop, review and update Engineering, Manufacturing & Inspection Standard Operating Procedures.
  • 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 of change controls for Manufacturing/Inspection/Engineering
  • 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
  • Support 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
  • Ownership of Level 1 non-conformances

Basic Qualifications:

  • Educated to degree level or equivalent.
  • Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization

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