May 20, 2022

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Ensure that all master data entries within Novartis responsibility are properly maintained reviewed and assessed in AQWA-A Auditing Module. Support all local sites and global groups by providing continuous AQWA support to guarantee data accuracy and uniformity across Novartis and ensure implementation of change management process is in place for master data modifications.
• Support Audit Process Improvement / Data Management projects (e.g. GxP initiatives, divestiture or External Supply Organization projects). Ensure data reliability & sustainability of Master Data in the Track-Wise auditing application (AQWA-Audit). Act as Support for Audit Process Improvement / Data Management projects
• Responsible for review and assessment of all site and target data within the GxP area and final approval of these new or changed records in order to activate and make them available in the AQWA Database.
• Ensure that all data collection and consolidation activities (e.g. all site and target categories reflect the database structure in line with business requirements) are per- formed in a most professional and accurate way based on predefined and aligned criteria with other divisional functions.
• Reflect Information based on Change Control requests according to the AQWA Audit Data Management SOP 7010113, e.g. create new sites or update existing ones to avoid unnecessary record creation.
• Ensure adequate handling within master data maintenance to guarantee data integrity and consistency including traceability of the change control activities. Ensure automatic scheduling is established where applicable and ensure alignment if needed.
• Support the Global Head Audit Planning and Data Management to establish the Annual GxP Audit Plan. Support Global teams in developing the Annual GxP Audit Plan. Perform “clean up” activities in AQWA as needed to ensure that not used sites are inactivated. Support Audit Planners within the responsibility area and according to the approved Annual Audit Plan.
• Maintain Master Data (sites, targets and audits) in AQWA up to date, including creation and actualization of records, attachment of documents, etc. based on input pro- vided by local sites and global groups (e.g. External Supply Organization, Technical Development).

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Education: Commercial business school, administrative expert, Pharmacy, Chemistry or another related science.
• 6+ years’ experience, in the pharmaceutical or biopharmaceutical industry.
• Excellent knowledge of computerized systems such as Track-Wise, SharePoint, SAP and proficient in all MS Office package.
• Strong interpersonal skills, excellent communication skills.
• Very accurate working style and good organizational skills, ability to work independently
• Good knowledge and understanding of organizational relationships within the pharmaceutical company.

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 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!

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
Novartis Technical Operations
Hyderabad, AP
Full Time
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Associate Manager Audit Data

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