337088BR
**Senior Product Steward**
Job Description
30+! The number of generic products that we manufacture at our facility.
Provides front line expert support for all product-specific issues related to Production, and continuous improvement of quality and efficiency. Ensures all product support is performed in compliance with cGMPs, SOPs, and applicable guidelines. Executes experiments to support product and/or process improvements. Supports relaunches, alternate sourcing projects, material qualifications, product transfers, and weak point product remediation activities.
Process/product oversight and knowledge:
Support maintenance of the oversight of the assigned products and related processes at the site (e.g. from raw materials to primary packaging and applicators as appropriate).
Support process and filling/packaging validation activities and weak point product remediation projects.
Support preparation and maintenance of product specific Quality Risk Analyses (QRAs).
Use scientific and statistical knowledge to analyze data to provide product understanding, and identify root causes of product and process failures.
Ongoing Process Verification (OPV), data trending and statistical analysis:
Track OPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Critical Quality Attributes CQA, Critical Material Attributes CMA, etc.) using statistical analysis and conducting regular product specific data trending.
Investigations/improvement on product:
Initiate and support compounding and/or packaging investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
Project execution:
Supports relaunches, alternate sourcing projects, material qualifications, product transfers, and weak point product remediation activities.
Validation:
Provide Quality Risk Assessment (QRA) documentation with Control Strategy prior to Validation.
Quality/Regulatory/Safety:
Adhere to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.
Testing Monograph oversight:
Provide oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content.
Change control:
Participate and/or lead (case by case) the change controls for the assigned raw materials, products, and related processes.
Annual Product Review/Product Quality Review (APR/PQR):
Supports process capability assessments.
Training:
Own the Training Curriculum for the role and provide the necessary training and support to new MS&T associates.
Audit support:
Maintain their work at an inspection readiness level and provide the necessary support to internal and external audits.
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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.*
Minimum requirements
B.S. in Pharmaceutical Sciences, Chemistry, Pharmacy or Chemical Engineering is required
Desirable M.S., PhD, or equivalent experience
Minimum of 3+ years experience in product/process support and/or shop floor is required
Experience working in a pharmaceutical product development capacity, especially in innovator and/or generic drug development is required
Experience in product development of semi-solids, liquids, and suspension dosage forms preferred
Experience with quality by design (QbD) and/or quality risk assessment (QRA) and design of experiments (DOE) preferred
Knowledge of FDA regulations and requirements, ANDA, IND/NDA processes and cGMPs
Sound experience of data handling and applied statistics is a must
769 million lives were touched by Novartis medicines in 2020, and while were proud of this, we know there is so much more we could do to help improve and extend peoples lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the worlds toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Accessibility and reasonable accommodation
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877) 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Division
Novartis Technical Operations
Business Unit
NTO SANDOZ TECHOPS
Country
USA
Work Location
Melville, NY
Company/Legal Entity
Eon Labs Inc
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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