Validation Officer - GMP
Summary: A leading Pharmaceutical Manufacturer featured in the top 100 companies to work for are now seeking an experienced Validation Officer to join them on a 1 year fixed term contract on their books.
Description: Validation Officer
A negotiable salary is on offer DOE + and excellent company benefits to accompany
Based in Cambridge
A leading Pharmaceutical Manufacturer featured in the top 100 companies to work for are now seeking an experienced Validation Officer to join them on a 1 year fixed term contract on their books.
The main purpose on your role is to ensure that these pharmaceutical products of are manufactured using equipment, processes and procedures that comply with the GxP requirements. These are specified by both the Regulatory Authorities and the employer. This will include supporting R&D, Production, Engineering and other departments, as appropriate to develop and maintain validated systems.
Reporting in to the Validation Team Leader your main job responsibilities are: -
*Provide input into Validation projects in accordance with GxP and departmental SOP's
*This will require you to ensure the completion of key milestones and the monitoring of documented evidence which verifies that such milestones have been met
*Support the introduction and validation of new equipment, processes and products
*This will include your participation in a multi-disciplinary team and assist in the development of documentation to support these activities
*This will be in compliance with company and project specific standards
*Carry out detailed assessments to support vendor qualification for specific validation projects
*Maintain the system for the ongoing review of validation projects including the filing, storage and retrieval of validation related documentation to ensure the compliance with Regulatory and corporate requirements
*Participate in the test phase of a project, acting either as a Tester or a Quality Assurance witness to verify test performance and outcome
*Where necessary you will need to produce technical reports to agreed standards
*Undertake any other tasks that are requested to help ensure that the highest standards of quality are achieved and maintained within the company's validated systems
*Documentation of Validation protocols and reports to provide evidence that manufacturing processes and equipment are validated and qualified to the requirements of GxP
Background I am seeking in you: -
*Previous Pharmaceutical regulations and requirements experience in a Validation based role
*Experience is essential in Process and Cleaning Validation and additional equipment Validation experience would also be advantageous
*Understand the principles of GMP and H&S
*Worked on a Quality Management System before
*Have knowledge of Regulatory Change Control
*Be a trained quality auditor
*Project management experience
*Have good attention to detail,
*Good time management skills, be a flexible team player who is an effective communicator
*Be able to problem solve using root cause analysis
*SOP and report writing
*Document reviewing and approvals
*Science or engineering degree or equivalent
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
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Validation Officer - GMP