Compliance Specialist

Compliance Specialist – Quality Control
To join our Life Sciences team in Vaud, we are looking for a Compliance Specialist – Quality Control.
The project :
Help the Quality Control (QC) team with daily compliance-related tasks.
Investigate and manage issues like deviations and non-conformities.
Review lab data to ensure it meets quality standards.
Handle documentation for deviations, investigations, CAPAs, and change controls.
Improve data integrity processes and report progress.
Write, review, and update procedures and quality documents.
Stay informed on new regulatory updates that affect QC.
Prepare for audits and communicate with auditors and regulatory agencies.
Suggest and implement process improvements.
Support training and make sure the team follows compliance training.
Work closely with QA and other departments to solve compliance issues.
Provide training on GxP regulations and best practices.
Stay current with industry standards and regulations.
Degree in Chemistry, Pharmacy, Biology, or Biotechnology,
Familiarity with Quality Systems (Deviation, CAPA, Change Control),
Knowledge of GMP/GLP and global regulations (ICH, FDA, EMA),
Experience in audits and regulatory interactions,
Ideally familiar with lab IT systems, digital tools, and lean methods,
Motivated, independent, and organized,
Good problem-solving and communication skills,
Team player,
Fluent in English (B2+); French is a plus.
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Role and Responsibilities
Ensuring the business/operational objectives of the new business requirements are well-defined.
Performing systematic business analysis.
Validating business requirements to ...
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Lead technical study into a propose solution, while involving expertise from infrastructure big data expert, business analyst requirement
Document proposed design and develop the solution
Implicitly ensure all CI-CD artefacts are part of the solution
Perform code review while fostering knowledge and coaching best practices to team members
Interact and provide reporting to project managers
Monitor technical risk and escalate appropriately to management
Research, design, and develop software.
Analyse user needs and develop software solutions
Update software, enhances existing software capabilities, and develops and direct software testing and validation procedures.
Work with other engineers to integrate hardware and/or software systems
The position requires autonomy and reliability in performing duties with initiatives and leadership when it comes to all non-functional deliverables such as testing tools, mocking objects, production monitoring concerns, quality control including performance and load testing.
Manage all aspects of project and program engagement from planning, external vendor relationships, communications, resources, budget, change, risks and issues
Continually manage stakeholder expectations through governance processes
Deliver appropriate and effective executive level communication
Provide status reporting regarding milestones, deliverable, dependencies, communicating across leadership and business stakeholders
Manage a portfolio of complex initiatives that span one or multiple lines of business
Own the full project life cycle end to end
Ensure the program is aligned to and supports strategic objectives
Prepare detailed project plan for all phases of the project
Manage the day-to-day project activities, including project management working and steering committees
Understand interdependencies between technology, operations and business needs
Monitor, track and control outcomes to resolve issues, conflicts, dependencies and critical path deliverables
Ensure that projects and programs are proceeding according to scope, schedule, budget and quality standards
Backend development and maintenance using Java and Spring Boot
Event-driven processing with Kafka
Deployment and orchestration using Kubernetes and Docker
CI/CD automation with ArgoCD
Frontend development with Angular 13
Collaboration and documentation via Confluence and Jira
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