Operations Documentation Specialist
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| Job Type | Contractor |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | Operations & Manufacturing |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002657 |
| Job Views | 846 |
- Description
- Team Horizon is seeking a Operations Documentation Specialist for our client’s site in Sligo on an initial 12-month contract. In this role you will be a key member of the project team for a new product being introduced by the client for their biologics site.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Co-ordinate and/pr 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 cGMPs.
Be a reliable point of contact for the manufacturing area for clear and precise communication of the documentation process and status of documents.
To coordinate processing of manufacturing documents into and out-of ABB Documentation Systems.
A key member of the operations readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the manufacturing documernts are prepared, executed and post approved in line with best practices and relecabt timelines.
Ensure highest Quality & Compliance standards.
Track and trend relevant operations and business process metrics to ensure operations are performance 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 and MBRs.
Assist in the preparation of progress reports/representations as required.
Revise, update, and format documentation including MBRs, SOPs, forms, logbook, and label templates.
Write/review manufacturing documentation (SOPs, Manufacturing Records & Logooks) ensuring it is current, accurate and in accordance with regulatory requirements.
Will act as an SME for the operations funcion and alsothe 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 production objectives, to provide support to production iniatives, to execute processes and procedures efficiently and compliantly, evaluates documents for improvement potential. Use standard practices to ensure inter-group consistency. Works within established systems to improve GMP and GDP compliance across the manufacturing department.
Schedules and executes tasks independently to support manufacturing schedule timelines. Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinate referrals across the cross-functional groups. Manages document review and approval to meet schedule timelines.
Exercises judgement within generally defined procedures and practices to determien 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 and implementation plan.
Investigates documentation related events in production that have quality or compliance impact. Leads or participates IIA, RCI sessions. Documents investigation outcomes.
Align processes with batch records. Provides training to ensure successful rollout of new batch records. Reponsible for inventory maintenance and MBR pre and post execution review and approval tracking.
Subject matter expert in SAP for inventory and production. Support production and inventory management.
Interface with planning to create and manage production process order number and batch numbers. Initiate and track blanket purchase orders for goods and services to support production.
Track weekly and monthly tield performance and report to department supervisision.
Frequently interacts with functional peer groups. Intercstion normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
Comply with policies and procedures, standards and specification, plant procedures, and regulatory agencies regulations and requirements.
Manage the manufacturing finite scheudle, including facilitating meetings, tracking adhereance to schedule and KPI monitoring and reporting.
What you need to apply:
Third level qualification to degree level in a relevant technical descipline (science).
Minimum of 3 years’ experience in the pharmaceutical industry or biopharma indsutry as QA documentation specialist or Operations documentation specialist.
Have knowledge of regulatory (FDA, HPRA) and technical requirements for biologics manufacture.
Proven ability to work cross-functionally.
