LSC have a great opportunity for a QA Specialist to join the QA team in 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 providing technical QA support to pharmaceutical or biotech manufacturing operations and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE ROLE:
- Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
- Quality review and approval of Validation documentation and SOPs to support site validation activities:
- Review of DS & QRAES documents
- Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or Engineering related discipline preferred.
- 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. Packaging, Inspection, Validation, Quality Control, Engineering, Information Systems)
- Understanding of principles of Validation and New Product Introduction
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Ability to operate across functional boundaries, both internal and external.
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organisational, communication, coordination, and meeting facilitation skills.
Apply directly via this advert or contact Kathy Gillen on 021 4718212 if you have any more questions about this opportunity!
Please note that we are unable to provide work permit or visa sponsorship
