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À propos
All potential applicants are encouraged to scroll through and read the complete job description before applying.
This is an initial 12 month contract role.
Responsibilities: Own and support validation activities in a Medical Device regulated environment.
Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned.
Generate Validation Plans, Protocols and Reports in support of assigned validation activity.
Resolution of Problems encountered during validation.
Ensure Consistency in validation/qualification approach across systems and projects.
Provide guidance and direction in the preparation and execution of validation activities.
Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
Maintain Validation system including conducting Periodic Reviews.
Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System modifications.
Assure ongoing compliance with quality and industry regulatory requirements.
Education and Experience: QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
Experience in working within a Medical Device Manufacturing / Pharmaceutical Environment.
Minimum of 1 year Quality Assurance / Regulatory affairs experience.
Experience of supporting or completing Process / Equipment / Facility / Utility / Software / Computer System Validation.
Experience in statistical Analysis / DOE and DMAIC methods.
Experience in using the GAMP 5 approach is preferable but not essential.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland
*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you.
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Skills: validation quality assurance medical devices
TPBN1_IJ
Compétences linguistiques
- English
Avis aux utilisateurs
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