Overview
Our client, a leading biopharmaceutical company, is keen to hire a Documentation Specialist to join their team on an initial 12-month contract in Sligo.
Responsibilities
* Co-ordinate and/or execute internal and external operations review and approval of all manufacturing related documentation.
* Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP’s.
* A key member on the operations readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the manufacturing documents are prepared, executed and post approved in line with best practices and relevant timelines.
* Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
* Assist in the preparation of progress reports/presentations as required.
* Revise, update, and format documentation including MBR’s, SOPs, forms, logbooks, and label templates.
* Write/review manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
* Exercises judgment within generally defined procedures and practices to determine appropriate action.
* Leads or participates IIA, RCI sessions.
* Responsible for Inventory maintenance and MBR pre and post execution review and approval tracking.
* Manage the Manufacturing Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.
Ideal background
* Bachelor’s Degree or equivalent preferential, preferably in a Science or related field
* Experience Level = 1+ Years
* Experience in a regulated manufacturing setting.
* Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred.
* Expertise with Outlook, Visio, Excel, PowerPoint is required.
* Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required.
* A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards
Note: This role is 100% onsite.
For a confidential discussion and more information on this Documentation Specialist role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060
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