We are looking for a QA Specialist 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 a QA Senior 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 new Fill line / Isolator and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)
- Quality review and approval of C & Q documentation
- Review of Risk Assessments, DS, URS & QRAES documents
- Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
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 new Fill line / Isolator
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
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!