Position Purpose : The key role is to provide excellence in stability trending and data extraction support to the sites, within the global network to drive the applications of statistical principles, tools and methodologies to improve process understanding, quality, compliance of the products, efficiency, capability of the processes and profitability of the organization.
You have to Timely prepare and review stability protocols and reports (Tech Ops and TRD), taking into account current regulatory requirements, requests from Health Authorities, general guidelines (e.g. ICH, FDA, etc.) and Novartis guidelines (e.g. NovStyle templates, etc.). Ensure Timely prepare and approve evaluation reports of stability data in support of Annual Product Reviews, Product Quality Reviews, etc. Compile and interprets stability data and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Have to Monitor stability data on a routine basis and communicates any adverse trends to management. Assures correct implementation of Testing Monographs to be used for the stability studies. Acts in the Change Control process as Evaluator for changes to stability parameters (e.g. shelf life) and for post-approval changes. He / She should archives stability related documents according to the requirements of the current Novartis Records Management Program. Perform Surveillance of Health Authority requirements, external stability guidelines, Novartis guidelines to ensure continuous compliance of the stability studies. Establishes proficiency on all stability related topics, such as deviations in product storage, transportation, etc. and provide experienced advice to customers (e.g. manufacturing sites and regulatory affairs).
Should support preparation for external inspections at Locarno according to the Novartis Pharma Corporate Quality Manual and answers questions during inspections.
Ensures implementation of associated corrective and preventive actions.
Has to provide assistance external inspections at customer sites on stability matters, related to assigned product responsibility.
Give assistance in implementation of associated corrective and preventive actions.
Any additional individual tasks/projects will be defined and documented during the course of the performance review process
Candidate Profile :
Education Qualification: Chemist or Pharmacist (MSc. or PhD from accredited Technical University) or equivalent education with experience in pharmaceutical industry
Language : Local language, English fluent in speaking / Writing Prior Work
Experience Preferred : 8-12 years Quality experience (QA and QC) in a manufacturing environment within the pharmaceutical industry. Experience in manufacturing desired. Sound knowledge in pharmacopoeial compendia, good knowledge of current regulatory requirements, guidelines and cGMP. Good know-how in common computer applications, i.e. MS Office, as well as in laboratory specific applications, e.g. LIMS, Chromeleon. EEO & Employment Eligibility : 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.
Job ID: 199471BR
Experience: 8-12 Years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 22nd November, 2016
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