The Validation Writer/Engineer will be responsible for writing validation documents for the implementation of a digital application to document our production batch record within the production lines, in replacement of a paper batch records.
Responsibilities
* Lead the validation activities to implement a digital batch record application in production.
* Support to input data.
* Write Validation protocol IQ/OQ.
* Execute the validation protocols.
* Complete the documentation following QMS guidelines (corrections / date format etc).
* Ensure the safety, security and wellbeing of yourself and colleagues are priority. You are responsible for raising and reporting any safety risks identified.
* Adherence to the QMS (Quality Management System) in all aspects of your role.
* Driving a safety-first approach maintaining a zero-accident culture, ensure accident prevention and environmental protection regulations of the facility to assure a safe and productive working environment free of any liabilities or defects.
* Prep work.
* Review current BRS/paperwork to confirm requirements.
* Layout the requirements in excel listing the required task lists, task list items and data collections, including system modelling requirements.
* Ensure product specifications are correctly documented.
* Liaise with manufacturing throughout to determine the correct data collection workflow and to ensure the draft layout is correct to their processes.
* Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
* Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.
Qualifications
* Computer literate
* Proficient with Word and Excel
* Understand the importance of validation, methodical
* Completes Quality Records clearly and concisely as per QMS requirements
* Driven / ability to work autonomously
* Able to transpose the correct data
* Attention to detail - must be able to provide the correct data
* Able to work closely with manufacturing to ensure the layout is correct from a compliance point but also works for production processes
* Must be able to listen to manufacturing and translate their needs
* Good communication skills
* Able to take clear and concise notes
* Write instructions in a clear and concise manner for documents
* Not be afraid to question - if it doesn\'t feel right get someone to check it before updating it
* Able to use PowerPoint
* Confidence to deliver the training sessions and drop-in sessions in front of an audience of 10 people
* You will be able to manage time effectively and possess a desire to succeed.
* You will have a flexible approach and ability to adapt according to workload.
* You are self motivated, reliable, able to work on own initiative, manage time effectively and possess a desire to succeed
* You will be an effective team member and able to communicate across functions.
* Rullion celebrates and supports diversity and is committed to ensuring equal opportunities for both employees and applicants
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