LSC have an exciting contract opportunity for an experienced QA Validation Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 5+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet site and regulatory expectations.
* Quality review and approval of Process Development and Validation documentation
o Technical transfer documents
o Validation Protocols, executed validation documents and reports
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
* Perform all activities in compliance with site safety standards and SOPs
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* University degree. Science or Engineering related discipline preferred.
* Deep 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)
Apply via this advert or contact Kathy Gillen on 021 4718212 if you have any more questions about this opportunity!
Applicants for these contracting opportunities in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship.
