LSC have a great contract opportunity for a External QA Quality Associate to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have 2 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
- Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
- Lead and support the development, implementation and continuous improvement of digital, AI-enabled and automation initiatives for External Quality.
- Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
- Responsible for development/reporting of metrics and supporting standardization of these across the Organization.
- Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO.
- Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's Degree in science or engineering.
- Minimum 2+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
- Skilled in data analysis and excel. Power bi and AI tool's experience desirable.
- Experience in Quality, Compliance, Regulatory Affairs, Manufacturing Quality or a related function.
- Experience working with Quality Management Systems and regulated processes.
- Experience supporting deviations, CAPAs, change control, inspections, audits or quality governance activities.
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 Jenny Murphy at LSC on 021 4777329 if you have any more questions about this role!
