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.