LSC have a great contract opportunity for a QC Planner 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:
- Create a rolling QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques.
- Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres - centres production, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and adhoc testing as required
- Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.
- Monitor plan execution - assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans if required.
- Initiates, manage, coordinate change controls and deviations for the QC department as required. Facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs are implemented
- Apply project management concepts and techniques, as they relate to planning and test method execution, to meet established delivery timeline.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment
- Experience in planning and project management
- A minimum of 2-3 years' experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
- Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.
- Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
- Ability to work cross-functionally and manage relationships with stakeholders.
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!
