Quality Assurance Specialist

Job description
Quality Assurance Advisor in Gothenburg

We are now looking for a Quality Assurance Advisor for one of our biggest clients. The client is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. 

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. The pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the projects in the development phase.

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities. 

Responsibilities
The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Typical Accountabilities:
Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
Provide appropriate Quality Assurance input to business improvement projects
Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working


Qualifications
Minimum requirements – Education and Experience
Degree in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment
Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
Comprehensive understanding of the pharmaceutical/drug development process
Good communicator with experience of interacting effectively across interfaces
Understanding of Project Management processes
Fluent in written and spoken English

Preferred requirements
Experience preferably within a pharmaceutical manufacturing organization
Good team working and networking skills
Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
Demonstrate a high degree of personal credibility


About the company
About randstad life sciences
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

For more information: Please contact Yonis Ismail, yonis.ismail@randstad.se