Senior QA Validation Specialist

Aug 03, 2021

Job Description

769 million. That’s how many lives are touched by Novartis products globally. And, while we’re proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives?

Senior QA Validation Specialist is responsible for quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet Novartis, AAA and regulatory requirements.

Your responsibilities include, but are not limited to:

• Author, review and approve validation and qualification procedures, plans, protocols and reports. Train and guide site personnel in validation area.
• Review and approve changes, deviations and procedures related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Perform QA oversight for Validation and Qualifications activities for Manufacturing and QC studies.
• Perform qualification and validation coaching and training for the quality team and other associates within Production and QC.
• Ensure timely escalation of risks in meeting timelines are communicated.
• Support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits. Provide guidance on audit preparations or leading investigations whenever required.
• Provide support to peers within the QA Operations team.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.

Diversity & Inclusion / EEO

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

What you'll bring to the role:

Bachelor’s Degree in a scientific or health related field
5+ years of experience in a GMP production environment
3+ years of experience in a QA validation role

• Collaborating across boundaries
• Functional Breadth
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
• Practical experience in facility changes and validation as well as successfully managing inspections from major Health Authorities including USA, EMEA, Canada, Japan, Brazil
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
• Knowledge of GMP and regulations, including FDA regulations 21 CFR Part 11 for computerized systems
• Knowledge of IT Applications & tools
• Quality oriented with attention to detail
• Strong organizational and time management skills

Why Advanced Accelerator Applications (AAA)?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking 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 world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Indianapolis, IN
Full Time
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Senior QA Validation Specialist

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