Quality Validation Specialist – CAPEX Projects

Vor 4 Tagen


YverdonlesBains, Schweiz gloor&lang AG Vollzeit
QA site Representative – French required
  • Our client is a leading biopharmaceutical company, renowned for its globally recognized product portfolio. To support a significant ongoing investment project, we are seeking an experienced QA Representative Manager to join their Pharma Operations team.
  • In this role, you will represent Quality in cross-functional project teams, providing oversight for commissioning, equipment qualification, and Computerized System Validation (CSV). Your primary mission will be to ensure all quality aspects are managed efficiently and in compliance with global policies, SOPs, GMP standards, and regulatory requirements.
  • As a senior professional in Quality Projects, you may also take on specialized tasks in cross-functional initiatives, contributing to the success of transformative projects.

This specific assignment shall be started ASAP and is planned for 6 months with high probability of prolongation till end of 2025

Project CAPEX Support:

  • Serve as the Quality Validation representative for site and global project implementation.
  • Provide quality and compliance expertise for validation activities, including equipment, utilities, room qualification, and Computerized System Validation (CSV).
  • Collaborate with project teams to resolve quality issues and plan QA activities.
  • Review and approve design documents, risk assessments, validation protocols, reports, deviations, and change controls.

Quality Assurance Activities:

  • Promote compliance with data integrity and computer system validation regulations.
  • Support the lifecycle of the strategic Quality Operations plan.
  • Develop and implement QA training programs for production lines and associated processes.
  • Perform quality risk assessments and support deviations and change control evaluations.

Operational Excellence:

  • Demonstrate flexibility and dedication to meet project deadlines.
  • Ensure effective communication between project stakeholders and within QA teams.
  • Actively promote EHS policies, ensuring safety practices are implemented and followed.

Qualifications:

  • Proven experience in Quality Validation, specifically in pharmaceutical or biopharmaceutical environments.
  • Expertise in CAPEX projects, equipment, utilities, and process validation.
  • Familiarity with cGxPs, regulatory guidance, and industry standards.
  • Strong organizational, analytical, and problem-solving skills.
  • Team player with the ability to work independently and drive cross-functional collaboration.

Why Join?

  • Be part of a globally recognized leader in biopharmaceutical innovation.
  • Collaborate on impactful projects that shape the future of healthcare.
  • Work in a dynamic and inclusive environment that values growth and excellence.


  • Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    QA site Representative – French requiredOur client is a leading biopharmaceutical company, renowned for its globally recognized product portfolio. To support a significant ongoing investment project, we are seeking an experienced QA Representative Manager to join their Pharma Operations team.In this role, you will represent Quality in cross-functional...


  • Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

    QA Site Representative – French RequiredWe are seeking an experienced QA Representative Manager to join our client's Pharma Operations team.This role will involve representing Quality in cross-functional project teams, providing oversight for commissioning, equipment qualification, and Computerized System Validation (CSV).The primary mission is to ensure...

  • QA IT MES Specialist

    Vor 4 Tagen


    Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    Joint skills in QA and IT required! French speaking job Join a Global Leader in Biopharmaceutical Innovation ASAP | Initial Contract: 6 months (extension highly probable until end of 2025) As a QA IT MES Specialist, you will be at the forefront of ensuring excellence and compliance during the implementation of an electronic batch record system. With a...


  • Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    Joint skills in QA and IT required! French speaking jobJoin a Global Leader in Biopharmaceutical InnovationASAP | Initial Contract: 6 months (extension highly probable until end of 2025)As a QA IT MES Specialist, you will be at the forefront of ensuring excellence and compliance during the implementation of an electronic batch record system. With a strong...


  • Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

    Join a Global Leader in Biopharmaceutical InnovationWe are seeking a skilled QA IT MES Specialist to join our team at gloor&lang AG.Job Overview:Ensure excellence and compliance during the implementation of an electronic batch record system.Work alongside cross-functional teams to uphold the highest standards of quality and compliance.Key...


  • Yverdon-les-Bains, Waadt, Schweiz Symbios Orthopédie SA Vollzeit

    Internship in Quality Insurance, MicrobiologySymbios Orthopédie SA is a Swiss medical technology company and the leader in custom-made orthopedic implants for hip and knee. With over 30 years of experience, we have pioneered and continuously improved custom implant manufacturing technology, becoming the world's most experienced company in this field.In our...


  • Yverdon-les-Bains, Schweiz Symbios Orthopédie S.A. Vollzeit

    Yverdon-les-Bains Posté il y a 13 minutes In our Quality Assurance & Regulatory Affairs Team, we are currently offering an Internship in Quality Assurance, Microbiology (6 Months) **Key responsibilities**: Ensure feasibility of studies link to the monitoring program on medical devices (Audit dose verification, Bioburden, Endotoxin, Cleaning residues test...


  • Yverdon-les-Bains, Schweiz Symbios Orthopédie SA Vollzeit

    Symbios is a Swiss medical technology company, and the leader in custom-made orthopedic implants for hip and knee. Since its creation, and thanks to its 30 years of experience, Symbios has pioneered and constantly improved custom implant manufacturing technology, becoming the company with the greatest expertise in this field worldwide. The company employs...

  • Project Manager

    Vor 3 Tagen


    Plan-les-Ouates, Schweiz Spineart SA Vollzeit

    Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients. Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive...

  • Project Manager

    Vor 5 Tagen


    Plan-les-Ouates, Schweiz Spineart SA Vollzeit

    Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients. Spineart is a pioneer in its field, having introduced unique patented and clinically validated technologies in the fields of Minimally Invasive...


  • Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

    IT MES Project Manager OpportunityWe are seeking an experienced IT MES Project Manager to lead the implementation of cutting-edge digital solutions in a new state-of-the-art facility. As a key member of our dynamic team, you will have the opportunity to contribute to breakthrough projects in a globally recognized organization.Your Key Responsibilities...


  • 1400 Yverdon-les-Bains, Schweiz Symbios Orthopédie SA Vollzeit

    This position of Quality assurance intern specialized in the microbiological fields will support the QA&RA department for the Biosafety topic.   Key responsibilities :   Ensure feasibility of studies link to the monitoring program on medical devices (Audit dose verification, Bioburden, Endotoxin, Cleaning residues test (THC /TOC). Ensure the...


  • Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

    Seize the opportunity to drive innovation and shape the future of Pharma IT with a renowned international biopharmaceutical company headquartered in Switzerland.Job SummaryWe are seeking an experienced IT MES Project Manager to lead our Investment Projects, fostering collaboration and excellence across global teams. As a key member of our dynamic team, you...

  • Project Manager

    vor 5 Monaten


    Plan-les-Ouates, Schweiz Spineart SA Vollzeit

    We are looking for a **Project Manager**. As a member of the **Research and Development **Team you will play an integral part in helping Spineart drive the medical technology industry forward through transforming patient care and creating better patient outcomes. You will lead the design and development of surgical instruments and implants medical devices...


  • Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    Contractor - 12 months – Investment Projects Are you ready to shape the future of Pharma IT? Our client, a renowned international biopharmaceutical company headquartered in the French-speaking part of Switzerland, is seeking an IT MES Project Manager. Join a dynamic team to implement cutting-edge digital solutions in a new state-of-the-art facility. With a...


  • Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    Contractor - 12 months – Investment Projects Are you ready to shape the future of Pharma IT? Our client, a renowned international biopharmaceutical company headquartered in the French-speaking part of Switzerland, is seeking an IT MES Project Manager. Join a dynamic team to implement cutting-edge digital solutions in a new state-of-the-art facility. With a...


  • Yverdon-les-Bains, Schweiz gloor&lang AG Vollzeit

    Contractor - 12 months – Investment ProjectsAre you ready to shape the future of Pharma IT? Our client, a renowned international biopharmaceutical company headquartered in the French-speaking part of Switzerland, is seeking an IT MES Project Manager. Join a dynamic team to implement cutting-edge digital solutions in a new state-of-the-art facility. With a...


  • Yverdon-les-Bains, Waadt, Schweiz Symbios Orthopédie SA Vollzeit

    About Symbios Orthopédie SASymbios is a leading Swiss medical technology company specializing in custom-made orthopedic implants for hip and knee. With over 30 years of experience, we have pioneered and continuously improved custom implant manufacturing technology, earning our position as the company with the greatest expertise in this field worldwide.Our...

  • R&d Project Manager

    vor 1 Woche


    Plan-les-Ouates, Schweiz Axepta Vollzeit

    We are looking for an **R&D Project Manager**, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices. Join an innovator in the field of surgery, located in Geneva. **Responsibilities**: - Contribute to the design and development of new products - Coordinate multiple projects simultaneously - Interact with the...


  • Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    **Summary** The main purpose of the job is to oversee the daily accounting operation of the Bioplant, maintain an adequate system of accounting records, and a comprehensive set of controls and budgets designed to enhance the accuracy of the company's reported financial results, and ensure that reported results comply with generally accepted accounting...