Description
Validation Engineer - Limerick - 12 Months Contract - Up to 43 EUR (Per Hour)
Support the activities of Operations/Engineering/Information Management in assuring compliance with the pertinent regulations.
Work with all departments in ensuring operational effectiveness and developing product quality for business continuity and process/product introductions.
Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
Implement policies and procedures.
Responsibilities:
* Responsible for supporting the activities of Operations/Engineering/Information Management in building product quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
* Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
* Runs/Manages complaint investigation and resolution of same
* Designs and develops validation documentation to support business continuity, new process introductions
* Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
Education and Experience Required for Role
Essential:
* Bachelors degree from accredited college
* Experience in a Quality function within the Medical Device/Pharmaceutical industry.
* Have good knowledge of statistical techniques in the use of problem solving/data analysis.
* Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
* Ability to demonstrate standards of leadership
* Flexible
* Team Player
* Good Influencing Skills
* Good generalist
* Good communication skills
* Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.