Description
World Leading Pharmaceutical client based in Cork have a long term contract requirement for an experienced Qualification Engineer.As part of an ongoing investment programme in new manufacturing equipment and line expansion, we are looking for an experienced QA Validation or Qualification Engineer to join a small team of three engineers and be involved in the review and sign off of qualification documentation.
This will involve reviewing documentation such as: SOP's, IQ OQ & PQ protocols for the new API equipment and re-validation of existing equipment.
API Equipment will include: Reactors, Millers, Filters & Dryers; and ideally, we are seeking candidates who have previously worked within an API environment.
Duties will involve reviewing existing documentation, including results, check sheets & sign off.
To be successful for this position we are seeking the following skills & experience:-
* Qualification & Validation background within an API manufacturing environment
* Production, review and approval of cGMP documentation
* Writing Validaiton protocols & reports
* Dedicated to GMP Quality & Quality Awareness
* QA review & approval of all validation related documentation