06 Sep
|
Novartis
|
Hyderabad
06 Sep
Novartis
Hyderabad
Summary:
About the Role:
Major accountabilities:
- Conduct gap assessment and define system design and configuration
- Identify, align & facilitate harmonization opportunities of global processes in TRD
- Drive Standardization and Normalization of Global/Organization/Site Static Master Data
- Liaises with System and Process Owners and actively contributes and participates in the System Governance and Change Advisory Board.
- Align changes and ensure adherence to standards
- Assess risk, conduct RCA and perform impact assessments for changes and problems
- Establish and own URS and be responsible for informal and formal testing and validation UAT / OQ / PQ
- Actively contribute to team goals
- Ensure compliance of processes with regulations as well as Novartis internal procedures and GxP requirements.
- Support and foster spirit of an inspired, curious and agile learning organization, including best practice sharing across digitalization projects.
- Acts as role model for Novartis values and behaviours.
- Minimum Requirements:
- Bachelors/Masters in Life Science or Information technology (e.g., analytical / organic chemistry / pharmacy / pharmaceutical development, IT) or equivalent.
- Knowledge in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
- 5+ years professional experience in relevant area.
- Good scientific background, communication skills including presentation and scientific/technical writing.
- Experienced in GMP workplace, with familiarity of IT systems (e.g. eLN, LIMS, SAP), and interfaces between different data tools.
- Comprehensive knowledge about project management, excellent organization and planning skills.
- Proven track record in successfully leading and working with interdisciplinary teams.
- Strong innovation mindset and problem solving skills.
- Strong communication and presentation skills. Advanced coaching skills.
- Ability to work in interdisciplinary global teams.
Be
📌 Expert Data (Hyderabad)
🏢 Novartis
📍 Hyderabad