Job Description
We are seeking a highly skilled Senior QA Specialist to join our team. As a Senior QA Specialist, you will be responsible for ensuring the quality of our products and processes.
Your primary duties will include:
* Acting as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products
* Quality review and approval of Process Development and Validation documentation
* Technical transfer documents
* Validation Protocols, executed validation documents and reports
You will also provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records.
Required Skills and Qualifications
To be successful in this role, you must have:
* University degree
* Science or Engineering related discipline preferred
* Understanding of principles of Validation and New Product Introduction
* Experience in aseptic manufacturing
* Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Benefits
This is an excellent opportunity to work with a dynamic team and contribute to the success of our company.
Others
Please note that applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa.