Novartis
Overview
Process Expert Deviation Investigator (Mon-Fri 8am - 5pm). As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions. Base pay range
$40.00/hr - $40.00/hr :::Please note: This is a temporary contractor opportunity at Novartis:::
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! Key Responsibilities
Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed. Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers. Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging. Ensure processes are always inspection ready. Support process optimization and new technology introduction for continued productivity improvement, as appropriate. Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. Provide guidance and support to production team through training and knowledge sharing. Demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures. Role Requirements
Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree. 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC. Proven process understanding (Pharma, GMP, Regulatory aspects). Strong awareness of quality issues. Compliance investigations experience required. Excellent technical writing skills. Desirable Requirements
Previous Radio pharma experience a plus Prior leadership and/or high cross-functional experience preferred. Location
Indianapolis, IN (Onsite) Contract
6-month Benefits and Notes
Health, dental, vision, 401k EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
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Process Expert Deviation Investigator (Mon-Fri 8am - 5pm). As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions. Base pay range
$40.00/hr - $40.00/hr :::Please note: This is a temporary contractor opportunity at Novartis:::
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! Key Responsibilities
Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed. Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers. Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging. Ensure processes are always inspection ready. Support process optimization and new technology introduction for continued productivity improvement, as appropriate. Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. Provide guidance and support to production team through training and knowledge sharing. Demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures. Role Requirements
Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree. 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC. Proven process understanding (Pharma, GMP, Regulatory aspects). Strong awareness of quality issues. Compliance investigations experience required. Excellent technical writing skills. Desirable Requirements
Previous Radio pharma experience a plus Prior leadership and/or high cross-functional experience preferred. Location
Indianapolis, IN (Onsite) Contract
6-month Benefits and Notes
Health, dental, vision, 401k EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
#J-18808-Ljbffr