Compliance and QA Validation Specialist
2 days ago
Description
• 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 • 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.
Requirements
• 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
Benefits
• 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
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