343357BR
May 17, 2022
USA

Job Description

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 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!

The Process Specialist will author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing and engineering department. Provide support to shop floor by triaging of unexpected events with PU Supervisors and QA team.

Your responsibilities include, but are not limited to:

Deviation and Investigation Management:
• Support the shop floor in the triage of unexpected events
• Open deviations within required timeframes
• Author investigations and support resolution of product complaints
• Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.

Corrective and Preventative Actions:
• Generation and documentation of effective corrective and preventative actions
• Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
• Monitor and ensure effectiveness checks of CAPAs are conducted
• Communicate to the production team any training or awareness events to reinforce quality behaviours.

Communication and Process Improvements:
• Provide timely updates to management on status of all GMP-related investigations
• Identifies opportunities for operational improvements for both manufacturing/engineering and deviation/investigation management
• Work with Scheduling, QA, to ensure that batches are released on time through the closure of robust investigations and impact assessments.

Quality Events:
• Owns and manages Quality Events related to GMP manufacturing
• Communicates, escalates, initiates, and owns trend events under the QE module. Ensure that the required CAPAs are communicated and created in order to eliminate or reduce reoccurrences.

Site Quality and Compliance
• Support the site during self-inspection, audit/inspection readiness and support the backroom/frontroom if required.
• Support the Novartis and Site Quality Plan, completion of site trend reports, APQR data gathering, and support KPI reporting.

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

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 Biology, Biological Chemistry, Pharmaceutical Technology, Pharmacy or scientific degree. Master's degree a plus

3 years’ experience in GMP manufacturing role on the shop floor and/or QA/QC, preferred
Proven process understanding (Pharma, GMP, Regulatory aspects).

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 embraces diversity, equal opportunity, and inclusion. 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.

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.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Technical Operations
Full Time
Regular
No
careers default image
343357BR

Process Specialist

Apply to Job Access Job Account