QA Compliance Expert Job in New Jersey (NJ), Laboratory Career, Full Time Jobs in Novartis Pharmaceuticals
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QA Compliance Expert job in East Hanover

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Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  248800BR
Employer:  Novartis Pharmaceuticals
Category:  Laboratory
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  East Hanover
Map: 
09/05/2018

Description
The Novartis Cell & Gene Technical Development and Manufacturing team is seeking a QA Compliance Expert in East Hanover, NJ.

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

The QA Compliance Expert will be responsible for providing compliance oversight services in the area of contract manufacturing of cell and gene therapy products and related materials.
•Maintaining tracking tools for Quality Risk Assessments, Quality Assurance Agreements and Contract Manufacturer Lists and working with Quality Assurance Managers to ensure their timely update
•Responsible to maintain the Document Management System for Cell and Gene Therapies Contract Manufacturing
•Ensuring that internally and externally generated GMP documents are properly uploaded and maintained at the assigned retention location
•Acting as a librarian for GMP documents in cooperation with assigned service functions
•Acting as single point of contact for the physical archive and the team sharepoint
•Providing support for creation, maintenance and retirement of standard operating procedures via the respective electronic database
•Maintaining the annual plans for Product Quality Reviews and working with Quality Assurance Managers to ensure their timely preparation
•Tracking tools up-to-date at all times
•GMP documents properly uploaded to the retention locations
•Standard operating procedures created and maintained within reasonable timelines
•New joiners fully on-boarded into the GMP environment
•No out of compliance situations as per the assigned tasks
Medium university degree in a business or technical subject (e.g. bachelor or master's degree in business administration)
Fluency in speaking / writing in English
Fluency in French (and/or German) would be an additional asset
•At least 5 years of experience in a pharmaceutical GMP environment, including working with databases, workflow tools and SharePoint
•Very good understanding of GMP documentation requirements, ideally with direct experience in a librarian function or equivalent
•Specific hands-on experience with Trackwise based workflow applications as well as Documentum based databases and SharePoint
•Know how on assembling APQR/PQR documents
•Experience with QA oversight on contract manufacturers
•Participation in technical projects would be an additional asset
•Team player with a clear service orientation in a multilingual and multi-cultural environment
ref: (248800BR)
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