347049BR
Jun 23, 2022
USA

Job Description

With 53 manufacturing sites across the globe, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.

A successful Deviation Specialist will perform and assist with the deviation investigation process for assigned deviations by applying technical, quality, and process skills to conduct investigations! Lead under the supervision and guidance of Deviation Manager the investigation of deviations that occur in operations. Work cross-functionally with Quality Assurance, Quality Control, Operations, Engineering, Maintenance, Calibration, Safety, and Supplier Quality Management to ensure appropriate and timely determination of scope, batch disposition, root cause, and corrective actions. Interact with all levels of staff and provide status updates as well as support the strategy for closure of deviations. Lead several investigations simultaneously.

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity & eCompliance
• Support exception investigations
• Review & approval of production, QC, and AS and T records
• MBR review
• Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

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

• High School Diploma is required
• Bachelor’s Degree is preferred
• 2+ years of technical writing experience in a GMP Pharma environment is required
• Experience writing deviations with Fishbone and 5Why's techniques is required
• TrackWise experience is preferred
• Oral Solid Dosage technology experience is preferred
• Strong communication skills are required.

Why consider Sandoz:

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine!

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

Accessibility and reasonable accommodations:
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 [email protected] 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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
Novartis Technical Operations
NTO SANDOZ TECHOPS
USA
Wilson, NC
Quality
Full Time
Regular
No
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347049BR

Deviation Specialist

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