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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.
Job 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.
Your attributes and skills:
- 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.
