Compliance and QA validation specialist
Castor
AT CASTOR, WE DRIVE FASTER, SMARTER MEDICAL RESEARCH
We believe that faster, more diverse clinical trials help extend the human health span and provide a greater return on investment.
We strive to improve the clinical trial experience for patients, sites and sponsors, using technology to accelerate every step of the clinical trial journey.
Our modular clinical trial platform enables the capture and re-use of research data from anywhere, anytime and helps optimize each activity in the clinical trial journey by reducing human effort with technology. From recruitment to monitoring, we help make it easier to design and deploy trials, enroll and engage patients, collect data and analyze results.
Next to being very purpose-driven, we are proud of our caring company culture. We follow our values diligently and take the well-being of each Castorian seriously. Sounds like something for you? Read on!
The main focus of the role
At Castor, we’re all committed to a world with faster, smarter, medical research. Our cloud-based software solutions are revolutionizing data capture for academic and commercial clinical researchers worldwide. You’ve found yourself a company with a true purpose.
You'll be joining a small team who believe compliance is more than just ticking boxes, we're setting new standards as we innovate in this area. As a our Compliance and QA validation specialist, you'll be involved in virtually every aspect of compliance internally, as well as with clients and suppliers.
What you’ll be doing
- Serve as a Subject Matter Expert of Quality Management System (QMS) to guide and educate Castor employees and clients
- Scheduling, facilitating and follow-up of client, internal and external audits
- Creating, tracking and following up on Corrective Action Preventive Actions (CAPAs) and Note to Files
- Supporting Managers in implementing workflow procedures based on their direction
- Providing customer and internal support in compliance related situations
- Oversight of Document Management, CAPA Management Systems, and Supplier Management
- Assist document owners with document reviews to ensure continuous improvement and CAPA corrective and preventative actions are being incorporated.
- Support oversight of Learning Management System
- Facilitate the procurement process of new suppliers (tools, services, consultants), including quality checks, requesting compliance documentation, monitoring extension of contracts and maintaining supplier information in our contract management system
- Responsible for overseeing all QMS Documentation and providing strategic guidance and recommendations to process owners
- You will be following the Castor quality policy, information security policy, the code of conduct and the procedures from the Quality and Information Security Management system (QISMS).
- Supporting Supplier Owners in Validation activities for GXP Suppliers
- Support Supplier owners in completing supplier validation/qualifications according to GXP and FDA 21 CFR Part 11 requirements.
- Perform Quality Assurance activities to create and execute test cases that provide sufficient evidence that the tool is functioning according to its specifications.
- Generate necessary evidence to demonstrate appropriate level of assurance that suppliers are able to consistently supply quality of output and services that are in compliance with regulatory requirements.
What you’ll bring
- Experience validating GXP computerized systems
- Familiarity with writing documents needed for implementation of new computerized systems such as URS (User requirements), Validation Plans, Test Cases, Operational Qualification Documents, Work Instructions, maintenance etc.
- Experience in a compliance focussed role
- An understanding and awareness of business/customer audit and documentation processes
- Ability to both, be able to collaborate with team members from all departments, while at the same time work with limited supervision.
- A strong attention to detail, with exceptional organization and prioritization skills
How Castor takes care of you
At Castor we truly live and breathe one of our core values, believing we can achieve anything with a healthy and happy team. Our benefits reflect this:
- Guaranteed ‘happy holidays’ bonus
- Employee Stock Option Plan
- Learning & Development Budget to support your growth
- Unlimited annual leave
- A fully remote role, with support for your home office set-up
- A flexible working schedule: nobody is tracking your time except you, we focus on output and delivery
- A great work-life balance
- Quarterly downtime weeks, access to OpenUp, well-being workshops, sleeping courses, virtual company events and celebrations
We are a remote-first company. At Castor, we value flexibility and believe that the best talents can work anywhere in the world. From flexibility improvements to productivity growth, we want to make sure you are happy, healthy, and productive while working from home.
Every Castorian counts. We celebrate you for who you are. We build products to make clinical research accessible to the world and a company where everyone, anywhere, is welcome. It does not matter where you are from, where you are based, or what your gender, age, or sexual orientation is.
Our remote-first setup is for your family, your work-life balance, your mental health, and your right to be your most authentic self. You are celebrated for who you are, for all the differences and quirks that define you. We want your unique voice to be heard and succeed together as a happy and healthy team!
Castor continues to grow as an Equal Opportunities Employer. We strongly encourage applications from women, people of color, and people from the LGBTQ(+) community. Please feel free to share the pronouns you use (for example she/her/hers, he/her/his, they/them/theirs, etc.).