QA Floor Specialist, Operations - SANDOZ - Morris Plains - Wizbii

QA Floor Specialist, Operations

  • Par SANDOZ
  • Morris Plains (United States)
  • Qualité / Sécurité / Hygiène
2018-07-18T21:26:40+0000

Description de l'offre

Job Description

This position will be expected to work a 4 day/10 hr work shift. (Sunday through Wednesday or Wednesday through Saturday, some evenings may be required) • Provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise. • Review and audit production batch records to ensure adherence to Novartis policies, SOPs, and cGMP requirements. • Interface closely with the QA Batch Release Managers and Specialists/PU to assist with batch record release and compliance issues. • Initiate deviation reports in Trackwise and partner with the QA Batch Release Managers and Specialists/PU for issue resolution. • Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation. • Ensures adequate levels of documentation are adequate and compliant to existing procedures • Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings • Implements and ensures adherence of appropriate regulations and Novartis quality standards. • Write, review and approve Standard Operating Procedures (SOPs), as needed • Present systems and provide documentation for self-inspections and external audits. • Interact with FDA, partner and supplier auditors/inspectors as needed. • Champion a Quality Culture and ensure a safe working environment. • Represent QA at corporate and site operational and cross-functional meetings, providing QA input and disseminating information back to QA as needed. • Complete job-related training as required
Posting Title

QA Floor Specialist, Operations

Profil recherché

Minimum requirements

BS/BA in Biological Sciences or equivalent relevant career experience may be accepted. Fluent in speaking and writing English. • 3 + years of experience in a Pharmaceuticals environment. • Knowledge and understanding of cGMPs, keeping up to date with current industryissues and changing regulations.
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
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.
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À propos de SANDOZ

Sandoz, une division de Novartis, est un leader mondial parmi les fabricants de médicaments génériques. Sandoz (26400 collaborateurs répartis parmi 130 pays avec un CA de 9.6 milliards USD en 2014) met à disposition des patients et des professionnels de santé des médicaments de qualité dont les prix maitrisés facilitent l’accès aux soins et contribuent à l’optimisation des dépenses de santé. Sandoz France fonde son développement sur la confiance des patients, de ses clients, de ses partenaires et appuie son succès sur : une recherche permanente de l’innovation, tant pour ses produits (génériques et biosimilaires) que pour ses actions ; Un portefeuille large, qui inclut une offre croissante de biosimilaires et qui répond aux besoins essentiels de santé publique ; Le savoir-faire industriel du Groupe Novartis, et de plus de 40 partenaires français ; L’engagement d’équipes fières et responsables, réunies autour d’une vision commune et de valeurs partagées.

1084 jobs disponibles chez SANDOZ

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