Our client, a leading Pharmaceutical company, is seeking a Documentation Specialist to join their Sligo team on an initial 6-month contract.
RESPONSIBILITIES
- Coordinate and/or execute internal and external review and approval of all Laboratory related documentation.
- Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP’s.
- Be a reliable point of contact for the laboratory area for clear and precise communication of the documentation process and status of documents.
- To coordinate the processing of laboratory documents into and out of ABB Documentation systems.
- A key member on the laboratory readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the laboratory documents are prepared, executed and post-approved in line with best practices and relevant timelines.
- Ensure the highest Quality & Compliance standards.
- Track and trend relevant laboratory and business process metrics to ensure the laboratory is performing effectively and efficiently.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
- Support the generation of efficient, user-friendly documentation, including SOPs.
- Assist in the preparation of progress reports/presentations as required.
- Revise, update, and format documentation, including SOPs, forms, and logbooks.
- Write/review laboratory documentation (SOPs & Logbooks), ensuring it is current, accurate and in accordance with regulatory requirements.
- Will act as an SME for the laboratory function and also the wider organization in adherence to GDP guidelines.
- Will be flexible to take on additional tasks and responsibilities at the discretion of their manager.
- Applies knowledge, experience, and technical skills to understand laboratory objectives, to provide support to laboratory initiatives, to execute processes and procedures efficiently and compliantly, and evaluates documents for improvement potential.
- Use standard practices to ensure inter-group consistency. Works within established systems to improve Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the laboratory department.
- Schedules and executes tasks, with limited assistance, to support laboratory schedule timelines.
- Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinates referrals across the cross-functional groups.
- Manages document review and approval to meet schedule timelines.
- Exercises judgment within generally defined procedures and practices to determine appropriate action.
- Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems.
- Presents a potential solution to management/senior personnel and with assistance, creates an implementation plan.
- Investigates Documentation related events in production that have a quality or compliance impact.
- Leads or participates IIA, RCI sessions.
- Documents investigation outcomes.
- Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
- Comply with AbbVie policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.
- Manage the laboratory Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.
REQUIREMENTS
- Bachelor’s Degree or equivalent is preferential, preferably in a Science or related field
- Experience Level = 1+ Years
- Experience in a regulated laboratory setting.
- Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred.
- Expertise with Microsoft Word, with a solid understanding of the review and formatting tools, is required.
- Expertise with Outlook, Visio, Excel, and PowerPoint is required.
- Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required.
- Experience with the use of electronic systems to manage, edit and control documents is preferred.
- A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards
- Previous experience in a fast-paced and deadline driven environment is required.
For a confidential discussion and more information on the role, please contact Emma Daly
emma.daly@collinsmcnicholas.ie
0861041202
