Validation Writer / Administrator

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.