Job Description
We are privileged to represent a client comprised of recognised global leaders and innovators in their therapeutic field.
This young start-up company has set out to develop first in class treatments that will transform the lives of patients.
Job Spec
To play a key role in developing Quality Assurance for this unique team of highly respected world class experts, you will have a passion for innovation, a drive and enthusiasm to create and establish Quality systems. Early start ups require a wide range of competencies that include the self-confident ability to put in place strategies, structures and procedures where none may yet exist, alongside the humility to occasionally role up sleeves and do what it takes to deliver in a fast growth environment.
Person Spec
You will possess a bachelor’s or Masters degree in a scientific discipline or related field with a minimum of 5 years experience in pharmaceutical Quality Assurance preferentially in clinical trials.
- Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
- Experience in implementation and administration of quality systems for drug Development, manufacturing and quality control operations.
- Skilled in writing regulatory submissions a distinct advantage.
- Strong written and oral communication skills.
- Has a thorough understanding of US and international regulatory requirements as they pertain to general Quality and/or Device regulations.
- Has a thorough understanding of the regulatory process from IND through commercialization.
- Ability to manage budgets and evolve as project needs change.
- Strong project management skills
CV to Gerry Kennedy The RFT Group gerry@rftgroup.ie 01 2302400