Compliance Specialist – Quality Control

To join our Life Sciences team in Vaud, we are looking for aCompliance 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.

CDI

Role and Responsibilities
Ensuring the business/operational objectives of the new business requirements are well-defined.
Performing systematic business analysis.
Validating business requirements to ...

CDI

• 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 usingJava andSpring Boot
• Event-driven processing withKafka
• Deployment and orchestration usingKubernetes andDocker
• CI/CD automation withArgoCD
• Frontend development withAngular 13
• Collaboration and documentation viaConfluence andJira