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Novartis
Millburn, NJ, United States
4 days ago
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East Hanover, NJ, United States
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Millburn, NJ, United States
26 days ago
Novartis
East Hanover, NJ, United States
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Novartis
Millburn, New Jersey, United States
4 days ago

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?

General responsibilities will include but are not limited to the following:

Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Approves Validation strategy and plans for the site.
- Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required
- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.
- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters
- Review/approve investigation of operations in manufacturing/laboratory or other related operations. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition and corrective actions
- Review and approve changes related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies.
- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
- Ensures supplier qualification activities are performed, including audits execution and Quality Agreements preparations.
- Contribute to the generation of the Annual Product Reviews.
- Primary SME for the GMP regulatory inspections, specifically for qualification and validation matters
- Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field

https://www.youtube.com/watch?v=4A1joFLTfo0

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

What you'll bring to the role:

Bachelors degree in Life Sciences. Masters degree preferred.
Experience / Professional requirements:
- 5 years of experience in Pharmaceutical Manufacturing, at least 3 years combined of relevant experience in QA Validation role.
- Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA's, e.g., USA, EMEA, Canada, Japan, Brazil
- In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 for computerized systems
- Strong organizational and time management skills.
- Quality oriented with attention to details.
- Highly proactive, self-motivated, professional and dedicated.

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: https://talentnetwork.novartis.com/network

Job Information

  • Job ID: 60957262
  • Location:
    Millburn, New Jersey, United States
  • Company Name: Novartis
  • Position Title: QA Validation Specialist
  • Job Function: Quality Assurance
  • Job Type: Full-Time
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