
Analytical Researcher
- Waterford
- Permanent
- Full-time
- Heavily involved, or occasion leading, scientific/technical investigations and develop approaches to solve wide ranging, difficult and complex problems.
- Working closely with product development teams and/or processes, characterisation, investigations and root cause analyses.
- Compilation and review of detailed technical documents.
- Ensuring that work is carried out in compliance with the required standards conforming to company, cGMP, GLP, SOP, regulatory, H&S and environmental requirements.
- Working cross-functionally with significant communication channels between departments such as Manufacturing, QC, QA, Regulatory Affairs and Operations to address deficiencies, fillings of new regulatory applications etc.
- Contributing to production of Module 3 regulatory submissions and associated correspondence with regulatory agencies.
- Delivering excellent customer service (both internal & external) through project timelines in accordance with company procedures & regulatory guidelines.
- Career experience within a Pharmaceutical laboratory setting.
- Experience working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.
- Knowledge of global regulatory and compliance requirements.
- Excellent planning and organising skills & adaptable to changing priorities.
- Bringing a breadth of data analysis skills.
- A confident communicator both verbally and in writing.
- Valuing colleague collaboration and team building.