QA Deviation Specialist

  • Par SANDOZ
  • Morris Plains (United States)
  • Qualité / Sécurité / Hygiène
2018-05-17T07:16:51+0000

Description de l'offre

Job Description

This position will be expected to work a M-F work shift. (some work may be required in the evenings and weekends) • Provides assistance to the QA Operation Batch Managers, Specialists and Associates to meet batch record review/disposition schedule in order to adhere to infusion schedule dates. • Ensure the deviation process meets Industry and Novartis expectations and requirements. Drives continuous improvement and enhancement efforts with regards to the management of Deviations to ensure an efficient yet Compliant process is maintained • Initiates, Reviews and Approves Deviations, OOSs, CAPAs, Quality Events to ensure adequate levels of documentation are adequate and compliant to existing procedures. Provides appropriate feedback as required. • Performs CAPA effectiveness checks as required. • Supports the coordination of activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to lead/facilitate investigations and to provide updates on discrepancy investigations; publish meeting minutes and action items from meetings; provide support to the investigation process and follow-up to ensure timely deviation closure. • Initiates Escalation activities as required. Participate in escalation meetings as required. • Performs trending analysis of deviations, CAPAs, OOS as required. • Supports APQR program with regards to providing analysis for deviations and CAPAs. • Supports the preparation and presentation of trend reports for Quality Management Reviews. • Implements and ensures adherence of appropriate regulations and Novartis quality standards.
Posting Title

QA Deviation Specialist

Profil recherché

Minimum requirements

BS/BA in Biological Sciences or equivalent relevant career experience Fluent in speaking/writing English Minimum of 7 years GMP manufacturing and/or QA related experience, at least 2 years of which are in the area of quality assurance and/or compliance or equivalent experience. • Experience in working in Analytical Development and/or Quality Control functions. • Strong planning, execution, interpersonal, commu-nication, negotiation and problem solving skills • Strong project management skills • Considerable organization awareness (e.g. interre-lationship of departments, business priorities), in-cluding significant experience working cross-functionally and in global teams
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.

Voici d'autres offres qui pourraient te plaire

Reçois les offres qui te correspondent par email !
Des milliers de jobs sont disponibles pour toi sur Wizbii :)

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.

1098 jobs disponibles chez SANDOZ

Trouve ton futur job sur Wizbii,
la 1ère plateforme professionnelle pour l’emploi des jeunes
Ton job dans la poche
Télécharger