Job Detail

Req #: 1804192


Location: Couvet, Neuchatel, Switzerland


Job Category: Quality


Work Location: Rue du Pré-Jorat 14 2108


Organization: Quality Operations


Employee Status: Full-time


Job Type: Regular

Competences
This position is within the Internal Manufacturing Quality Operations organization, reporting to the Associate Director (AD), Operations Quality Systems.

As part of the QA Documentation team, the Sr Specialist QA Documentation is responsible to support the Quality Documentation management system (DMS) and GMP/GDP Learning Management system (LMS), its maintenance and continuous improvement. In addition, the position holder supports the GMP/GDP Training management system, including the maintenance of the LMS.

Although this position covers primarily activities related to Celgene Internal Manufacturing in Couvet, support may be given, through the QA Documentation team, to other Internal Manufacturing sites like Boudry, Zofingen and Stockley Park (as needed).

Skills/Knowledge Required

• Economic or administrative degree or equivalent training/education.


• Must have experience with cGMP manufacturing, Quality and Compliance (minimum of 8 years), specifically in handling GMP/GDP Documentation & Training


• Good understanding of records management and retention policies


• Good understanding of Data Privacy regulations and its compliance


• Expertise in document technical writing/document authorship,


• Experience in effective training content design and development utilizing different tools (incl. e-learning, video…)


• Comfortable providing instructors led training (New Employees Orientation training/system access training…) and guidance to system users as needed.


• Good communication and ability to work effectively in a multicultural environment and multisites team.


• Must be well organized and self-directed


• Proactive and continuous improvement oriented


• Fluent in French and English

Duties and Responsibilities



As part of the QA Documentation team, the Sr Specialist Documentation acts as Administrator and Super-User of the electronic Documentation Management System and has the following responsibilities related to:




Documentation management

• Ensure Quality Documentation complies with established Celgene electronic Documentation System standards & document management policies (act as document reviewer/approver)


• Provide timely and efficient support to systems users in handling document workflows and managing document change requests


• Monitor progress of documents through the electronic workflows


• Proactively manage the Periodic Review Process of quality documents


• Provide expertise to site authors on document technical writing and effective document design


• Assist with the documentation and training management systems document authoring

Documentation and data retention:

• Ensure documentation/data are physically and electronically archived and retained in compliance with Regulations, Celgene policies and Data Integrity requirements.


• Initiate the annual documentation and data destruction process as per applicable standard.

The Sr Specialist Documentation acts as Administrator and Super-User of the electronic Learning Management System and has the following responsibilities related to
training management:

• Responsible for the creation and assignment of GMP/GDP training in Celgene electronic Learning Management system (ComplianceWire), as well as curriculum and user groups periodic review


• Create, update personnel training profiles according to the training management and Celservice requests

• Support training material authors in creating effective training content design (eg, E-learning tools, animated training, video)


• Deliver instructor led training associated with our “Train the Trainer program” and New Employee Orientation training


• Train end-users on the Documentation and Training processes and associated IT systems

The Sr Specialist Documentation will act as the Celgene EMA GPDO representative and point of contact in regards to Data Privacy related activities and regulations.

• Work closely with Global and Corporate representatives to ensure compliance to Data Privacy policies


• Communicate and ensure deployment of PAGE program initiative in collaboration with the respective Celgene EMA GPDO functions.

Prerequisites

Economic or administrative degree or equivalent training/education.

A minimum of 8 years of working experience in a pharmaceutical company or other related industry.

Experience in handing of GMP/GDP/Quality documentation.

Fluent in French and English.




About Us




COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE



At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.




"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."



There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.