Documentation Specialist

DOCUMENTATION SPECIALIST

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.

·       Be a reliable point of contact for the manufacturing area for clear and precise communication of the documentation process and status of documents.

·       To co-ordinate processing of manufacturing documents into and out-of ABB Documentation systems.

·       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.

·       Ensure highest Quality & Compliance standards.

·       Track and trend relevant operations and business process metrics to ensure operations are 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 and MBRs.

·       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.

·       Will act as an SME for the operations 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 Production objectives, to provide support to Production initiatives, 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 Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the manufacturing department.

·       Schedules and execute tasks, with limited assistance, 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 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 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.

·       Responsible 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 numbers and batch numbers.

·       Initiate and track blanket purchase orders for goods and services to support production.

·       Track weekly and monthly yield performance and report to Department supervision.

·       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.

·       Manage the Manufacturing Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.

REQUIREMENTS

·       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 Microsoft Word with a solid understanding of the review and formatting tools is required.

·       Expertise with Outlook, Visio, Excel, 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.