Your experience and qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or a related scientific discipline
- Minimum 2-year experience working in Quality Assurance, Compliance, or Regulatory roles within a GMP regulated environment
- Ability to simplify processes, identify bottlenecks and translate stakeholder feedback into clear processes
- Active listener and decision-making skills
- Team role player with strong analytical and critical thinking approach
- Knowledge of OPEX and implementation of time management tools (i.e. Daily Tier meetings, workplan boards)
- Hands on experience supporting regulatory authority inspections and external or internal audits
- Practical knowledge of CAPA management, including investigation follow up and effectiveness checks
- Good understanding of GMP principles, quality systems, and regulatory requirements (e.g., EMA, FDA, ICH)
- Experience working with suppliers or vendors, including audits, deviation investigations, or change controls
- Familiarity with Quality Technical Agreements (QTAs) and Site Master File maintenance is an advantage
- Ability to review quality performance data and support development of improvement action plans
- Strong documentation, organizational, and communication skills
- Ability to work independently, manage multiple priorities, and collaborate effectively with cross functional and global teams
- Ability to work independently while collaborating effectively with cross functional teams
- Fluent verbal and written communication skills in English