For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Opportunity
ProPharma is once again growing within our Compliance & Quality Assurance department and we are now looking to identify our newest permanent team member to work based out of Sweden. In the role of ‘Compliance and Quality Assurance Consultant (CQA)’, you will be responsible for supporting the management of compliance and quality assurance related projects and providing consulting and contract services to clients to address quality and regulatory / GMP / GDP issues, as needed.
Essential Functions:
Support our client with management of product quality complaints.
Supporting our clients with different GxP requests.
Represent the company in assigned areas of quality assurance
Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.
Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise. Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
Directly engage with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.
Other duties as assigned.
Educational Requirements:
Bachelor’s degree, or similar college degree, in a scientific discipline as a minimum
Experience Requirements:
Minimum 2 years relevant experience in quality assurance and regulatory / GxP compliance
Fluency in English is a must
Ideally you are fluent in Finnish or Swedish
Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information / instructions accurately
Knowledge of applicable EMA, MHRA regulations and guidance documents would be desirable
Ability to manage and execute multiple tasks within the compliance & quality assurance
Quality orientation and high attention to detail.
Strong analytical skills
Adaptable, eager to learn and results orientated
#LI-DNI
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***