Specialist, Quality Assurance eSystems
Bristol-Myers Squibb
Boudry, Switzerland
vor 6 Tg.
source : Experteer

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first.

At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients.

As we continue to pursue that mission, we're looking for talented professionals like you to join our team.This position is responsible for Quality Assurance (QA) eSystems maintenance, support and local administration in coordination with and with the support of the QA eSystems team.

The position holder will also be asked to support the other activities of the QA eSystems team ie Quality Oversight of IT Systems, Deviation Handling, Oracle EBS MDM Review / Approval etc.

In this position, you are responsible and accountable for : Acting as superuser / admin as required for the following systems, eQRMS, FileTrail, LiSI, Celdox, Oracle, QUADS and other systems as they are rolled out within the responsibility of the Quality Operations groupProviding strong support to QA eSystems Mailbox coordinator, ensuring that all requests and queries are being followed up and closed on timePerforming the review and approval of master data for the PTM process within the Oracle EBS SystemAs Directed and required, you will organize cGMP compliant system management and user trainingsParticipating in global project teams for the roll out of new global QA eSystems.

The position holder will participate and take responsibility for assigned tasks e.g. to plan, coordinate and execute activities related to the local implementation of new global QA eSystemsParticipating as directed in global project teams for changes and improvements on the various QA eSystemsProviding support (as required) to local QA IT projects relevant for the development of the International Quality Operations groupSupporting the team to handle deviations, CAPA, and Change Control related to eSystems and to ensure the execution and the follow up of escalation processes up to both site and the global levelWriting and assisting with writing SOPs, WPs, etc for QA eSystemsAs required, providing support to QA eSystems SMEs in topics regarding computerized and automated systems validation requirementsSkills / Knowledge Required for the role : At least 3 years of experience in Quality Control, Quality Assurance and / or IT in a pharmaceutical company or other related industry.

Technician (laboratory or other) or BSc / BA in Life Science or related experience.Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

Solid understanding of solid oral dosage form manufacturing / packaging and QC processes.Works independently, yet effectively in a team environment.

Good investigational skills and QA problem solving skills, has a keen eye for Quality.Good written & oral communication skills in both English and FrenchGood interpersonal and training skills.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.Full time

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