Role Responsibilities : Develop, review and update product support 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, To manage the administration of change control projects. 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. Qualifications & Experience: Educated to degree level or equivalent. Technical Writing experience gained within a biotech, pharma or health care organisation. Interested candidates should submit an updated CV. Please click the link below to apply, call Sean on 0214297900 or alternatively send an up to date CVsean.firstname.lastname@example.org. This job originally appeared on RecruitIreland.com.
196 days ago