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Validation Writer / Administrator
Job Posted: 2 hours ago
Salary: £ 12.6 - 12.6 / Hour
Job Type: Temporary
Location: Sudbury, Suffolk
Expire in: a month
Job Description
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 applicantsBefore You Apply
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