LSC have a great contract opportunity for a QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5+ years of industrial experience working in the biotechnology industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation, etc.
- Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
- Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
- Manage change control requests.
- Process product complaints.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc or equivalent in scientific discipline
- At least 5 years of experience in Quality Assurance in a pharmaceutical company.
- Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
- Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
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 Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!