Associate, QA Site Compliance (SQM)

Novartis - Wilson, NC (30+ days ago)4.1


This position supports the Supplier Quality Management (SQM) program for the Wilson site with a strong link to ESO group to support supplier quality related activities, as applicable and required. This position will primarily focus on supplier performance, Quality Agreement negotiation and maintenance, deviation/investigation support, CAPA follow up, for cause audits, supplier relation-ship management and interaction with other sister site Supplier Quality representatives in support of corporate objectives for new harmonized SQM processes and procedures. Provide support for activities related to Supplier Quality and help maintain the overall compliance status of the site. Responsibilities include supporting all the Supplier Quality related activities for the site including support for the global ESO supplier management. In addition to that, this role may also assist in site preparedness for inspections by regulatory authorities as guided by the Site Compliance Director, execution of compliance activities such as site procedural and cGMP training, internal audits, and Novartis Quality Module knowledge. May also assist in maintaining and developing quality system in line with current local regulations in Pharmaceutical industry, as well as corporate guidelines of Novartis and operational guidelines. To prepare and maintain supplier quality and quality system documentation and corresponding registers (Investigations, Change Control, CAPA, Product Reviews, etc.) • To participate in audits and GMP-related training for internal and external customers; • To participate of self-inspections on site • To maintain supplier qualification files (questionnaires, audit outcomes, quality agreements) and QA archive • To maintain the material suppliers application in SAP system (3 PAP Manufacturing Maintainer and AMC functionality) as a backup user. • Supplier qualification (as backup) May participate in the following functions: Participation in site periodic and PAI Inspections Maintenance of the Site Risk Management Program Execution of the Site Internal audit program Creation of Annual Product Reports (APR’s) Providing ANDA review support for regulatory submissions Novartis Quality Module compliance evaluation Review of changes for adherence to applicable Novartis Quality Standards Review of product stability discontinuations cGMP trend monitoring EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements

B.S life sciences Fluent in written and spoken English Minimum 10 years of Pharmaceutical experience (must include some QA/Compliance/Regulatory experience, preferably with 3rd Party management). Required knowledge of FDA GxP regulations and other global expectations

Division

Novartis Technical Operations

Business Unit

NTO QUALITY

Country

USA

Work Location

Wilson, NC

Company/Legal Entity

Eon Labs Inc

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular