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QA Analyst - GLP QA Officer
List of the main areas this job must achieve:
* Supervise GLP studies throughout their conduct for compliance with GLP principles
* Conduct QA reviews of SOPs and other quality documents for compliance with GLP
* Conduct QA process and study audits to assess compliance with GLP
* Support inspection readiness activities for GLP inspections
* Provide guidance to the teams for the implementation for GLP requirements
* Prepare and deliver quality and regulatory training
Technical know-how or competencies required:
* Meaningful experience in working in a Quality Programme as well as in preparing for or participating in regulatory inspections and accreditation programmes
* Proven track record in working in a GLP environment.
* In-depth knowledge of GLP regulatory requirements and their interpretation
* Knowledge of current Data Integrity best practices and processes implementation in laboratory environment (pharmaceutical, biological, biochemistry or analytical)
* Experience in a pharmaceutical/biological/biochemistry R&D environment with knowledge and review experience of in-vivo and in-vitro Research study protocols and reports is highly desirable
* Understanding of current technology trends for biological lab automation and digitalization is highly desirable
* Experience with ISO 17025 is highly desirable
* Direct experience with Regulatory Inspections is preferred
* Previous experience in working within a global, multi-functional, multidisciplinary and project oriented environment to ensure project and business alignment
* Proficiency in MS Office Suite
* Fluency in English, both written and spoken
* Organized, detail-oriented, able to prioritize and to perform tasks methodically, and to employ critical thinking in problem-solving
* Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to detail and presentation skills).
* Ability to initiate assigned tasks and to work independently
* Ability to evaluate quality matters, make decisions utilizing a pragmatic, risk-based approach and communicate effectively across all organizational levels
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