Scientific Technicial Writer

Pe Global

Dublin

The role. • Develop, review and update Standard Operating Procedures. • Update and review master batch records. • Review of batch documentation, both EBR and paper batch records. • Participation in Artwork meetings as part of coordination of specification changes that will lead to updates to SOPs, BOMs, EBRs or EBRA’s. o Develop Site Training material in conjunction with internal training teams. • Ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences. • Provide technical and clerical support to the production team in the preparation of documentation, collation of data and tracking of investigations. • Contribute and assists with various regulatory bodies during company audits. Qualifications. Educated to degree level. At least 2 years of related Quality Assurance/Tech Writer experience or in the pharmaceutical or medical device industry. Advanced word processing, report generation and design, database, and spreadsheet application skills. Knowledge and experience in Electronic Document Management applications, GMP or GDP. Proven interpersonal skills, with all levels, including the ability to manage conflict in a collaborative manner. Demonstrated ability in troubleshooting, problem solving, identifying and providing solutions to client and departmental requests. Please contact Emma on 021 4297 900 for more information or email an updated CV to emma.okeeffe@peglobal.net. This job originally appeared on RecruitIreland.com.

2487 days ago