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Quality Control (pharma)

  • Biochemistry
  • Budget
  • CGMPS
  • Chemistry
  • Inspections
  • Method Validation
  • Microbiological
  • Pharmaceutical Manufacturing
  • QA
  • Quality Assurance
Description:

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! 
  
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com 
  
Ready to work with/through Magnit at Novartis? Please read on... 
The Quality Assurance Engineer, is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the AAA Indianapolis radioligand manufacturing site.

Major Accountabilities:
• Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations, Quality Control and outside consultants and contractors to ensure that new facility is:
o Compliant with all appropriate Novartis QMS and regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing
o Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
o Capable of meeting intended design goals of output volume, turnaround time and operating and product costs.
• Acts as QA point of contact for Quality Control for activities including; release of raw materials, investigation review/approval, protocol approval, review/approval of method validation, etc.
• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes), CPPs (Critical Process Parameters), Finished Product testing and Microbiological programs.
• Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget.
• Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective.
• Work with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Collaborate with MS&T to ensure products are maintained in a validated stated.
• Author and/or approve Standard Operating Procedures in support of project activity and deliverables.
• Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing and testing facility in a GMP state.
• Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.
• Perform QA approval of major and critical investigations.
• Lead and support internal self-inspections.
• Other related duties as assigned.

Ideal Background:
Education - B.S. degree, preferably in chemistry or biochemistry.
Experiences -
• 5+ years of experience in a GxP pharmaceutical manufacturing operations
• 2+ years of experience in a quality assurance role

• Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
• Strong knowledge and experience of Quality Control testing and methodologies.
• Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch.
• Experience with radiopharmaceuticals is a plus.
• Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
• Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience participating in internal audits, identify findings, driving to resolution and providing closure report is desired.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
• Overseeing manufacturing and testing operations as a quality representative.

Competencies
• Continuous Learning (Dyn. Knowledge Development)
• Digital & Technology Savvy
• Operational Excellence
• Being Resilient
• Breakthrough Analysis
• Interpersonal Savvy
• Organizational Savvy

Location: Indianapolis, IN (Onsite) Scheduled: Mon-Fri (8:00am-5:00pm)
Pay Rate: $61.80-79.58/hour
Contract: 6 months 
Health, dental, vision, 401k

Why Novartis? 
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s 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 we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 
Imagine the impact you could make here at Novartis! 
  
Commitment to Diversity & Inclusion: 
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. 
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. 
  
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 or 1.862.778.5441. 

Commitment to Diversity and Inclusion / EEO

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen, Other valid work visa
  • Preferred years of experience : 5+ Years
  • Travel Required : No travel required
  • Shift timings: Onsite: Mon-Fri (8:00am-5:00pm)
Job Location
Indianapolis, Indiana
Pay
USD 61.80 - USD 79.58 Per Hour
CONTRACT DURATION
6 month(s)
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