LSC have a great contract opportunity for a QA Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Act as site lead for nominated quality systems (e.g. EDMS, Deviations, CAPA, Quality Management etc), responsible for trending review and resolution of issues
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed
- Support the development and implementation of improved quality reporting measures
- Aid the effective implementation of the relevant areas of Quality Management System
- Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis
- Actively participate in Plant/Quality committees and work with other site functional groups to help set direction for QMS related topics
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor Degree or higher preferred; ideally in a related Science discipline
- Knowledge of EU/US quality related pharmaceutical regulations
- Experience of Sterile manufacture preferred
- Ideally a minimum of 3 years' experience in the FDA and/or EU regulated pharmaceutical environment
- Proven ability to effectively initiate and drive change
- Strong verbal and written communication skills, project management skills
- Equipment and process validation
- Proficiency in Microsoft Office and job-related computer applications required
- Lean Six Sigma Methodology experience desired
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 Sarina Abdulha at LSC on 021 4777329 if you have any more questions about this role!
