Job Details
Job Ref: 213085923
Date: 2021-01-27 11:49:25
Inside IR 35
Based on site
The main purpose of the role is to support the effective management of the validation of processes / equipment / utilities / cleaning at the Milton Keynes sites.
Key roles include:
· Execute requalification of equipment, facilities and utilities and periodic review activities in accordance with the Validation Master Plan schedule
o Practical support during protocol execution where required and appropriate.
o Supervise validation testing performed by contractors to ensure work is accurately completed to the required standards
o Assists in developing programs and maintaining standard operating procedures (SOPs)
o Facilitation of the review and approval of validation documents.
· Lead and perform small to medium size validation activities by writing, reviewing, approving and executing documentation for new and current validation activities. This will include the validation of a new parts washer and the temperature mapping and cleaning validation of modified pipework.
· Generating validation technical reports related to systems, products and/or processes, in compliance with company standards and regulatory requirements.
· Review proposed Change Controls (low to mid complex changes) to assess the impact on the validated status and determine the validation strategy as required.
· Provision of advice and guidance on validation related topics and best practices.
· Communicate cross functionally regarding status of validation status and project timelines
· Identification and implementation of continuous improvement initiatives to ensure lean ways of working.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Who we are …
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization
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