At LSC we are looking for a QA Technical Support to join a Biotechnology company in Dublin. The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
If you have 7 years experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as Clean Utilities project and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide QA support and oversight for a range of technical projects, including New Product introduction to Packaging lines, introduction of new manufacturing equipment (ex: new packaging line, new AVI, new vessels, freezers, etc..)
- Quality review and approval of CQV documentation
- Review of Risk Assessments, DS, URS & QRAES documents
- Review of validation Plans, Protocols, FAT, SAT, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
- Perform all activities in compliance with Amgen safety standards and SOPs
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as Clean Utilities project
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organisational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Aoife Gleeson at LSC if you have anymore questions about this opportunity!