Description
Senior technical writer required to join a global pharmaceutical company in Ireland. A 12 month contract initially, with the technical writer responsible for working within the production area.Role and responsibilities:
. Develop, review and update production Standard Operating Procedures.
. Develop, review and update master/generic batch records, bills of materials etc.
. Review of batch documentation, both EBR and paper batch records.
. Involvement in Artwork meetings as part of coordination of specification changes that will lead to updates to SOPs, BOMs, EBRs or EBRA's
. Involvement in projects as part of continuous process improvement and/or troubleshooting, including
. Liaison with equipment line and system owners to troubleshoot and develop new ways of working
. Liaison with site training teams to enhance and develop the site procedures
. Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP's, batch documentation and licences.
. Liaise with Process Development regarding documentation changes in an effective and timely manner.
. Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including batch documentation, bills of materials and SOP's for submission to the Product Lead.
. 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 Corporate, FDA, HPRA Auditors and other regulatory bodies during company audits.
. Own and lead change controls as required by the Patient Supply organisation.
Requirements:
. Educated to degree level or equivalent.
. Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.
. Advanced word processing, report generation and design, database, and spreadsheet application skills and a thorough knowledge of Internet navigation.
. Fluency in English, both in oral and written communication.
. Strong communication and presentation skills.
. Strong attention to detail, including the ability to proofread documents and to accurately follow step-by-step instructions consistently.
. Thorough knowledge of document processing, distribution, imaging, and other departmental functions.
. Ideally, specialised knowledge and experience in Electronic Document Management applications, Good Manufacturing Practice (GMP) and regulatory knowledge with the ability to interpret and apply in non-routine cases, as related to document requirements.
If this is you please apply today.