Join a start-up company and play a key role in the development of its flagship production facility, overseeing the implementation of pharmaceutical quality systems and providing quality assurance oversight.
As the Quality Assurance Associate, you will collaboratively work with the design, engineering and operational teams to ensure a smooth and efficient handover and start-up operation of the facility, in compliance with regulatory expectations.
This role will be on a part time basis for 2 days per week during the initial set-up period and could potentially grow as the company expands.
Responsibilities will include:
Overseeing the performance of design reviews
Carrying out gap analysis on existing pharmaceutical quality system documentation
Generating and implementing pharmaceutical quality systems, in line with regulatory requirements
Actively liaising with subject matter experts, consultants and regulatory bodies
Supporting the staff recruitment and training process
Experience and skills required:
Hold a bachelor’s degree in biological sciences or a related discipline
Minimum 7 years’ post-degree work experience, ideally in the pharmaceutical, biotechnology or related industries
Confident using routine analytical instruments and techniques
Previous experience working with companies in Europe on setting up and managing quality systems in accordance with current good manufacturing practice regulations
Ability to provide technical and/or business solutions for complex problems which include assessing potential risks and impact
We are an equal opportunity employer and value diversity at all times.