• Sr. Manager - DI & System Compliance Jobs in Hyderabad,India - 25181457

  • Novartis AG
  • Save Job
  • 10 - 13 Years
  • Posted : 17 days ago

Job Description:

Job ID 265423BR

Position Title Sr Manager - DI & System Compliance

Your responsibilities include, but are not limited to

1Ensuring that all lab instrument/equipment software is compliant with MHRA and 21 CFR Part 11 data integrity requirements (following the Novartis IT requirements)
2Providing subject matter expertise on Data Integrity (DI) for business processes
3SPOC for Site DI network within GxP functional areas eg Manufacturing, MS&T, Engineering, etc
4Reporting of DI related KPIs, performing DI trainings and lead the communication of DI related topics
5Active member of Audit teams and address the audit observations raised during self-inspection and other audits
6Champion the Data Integrity aspect at the SDC India site Systems Compliance

7Support project teams and system owners on qualification procedures for timely execution of qualifications and creation/review of documents for validation and qualification (following the No-vartis IT requirements and addressing non-compliant issues)

8Support installation of software together with Dev IT and vendor and creation and maintenance of system data lifecycle documents

9Single point of contact between SDC India and local and global IT and other business partners, and part of a global business support team for the global

Why consider Novartis Group of Companies

817 million Thats how many lives our products touched in 2018 And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis group of companies Join us and help reimagine medicine

Minimum requirements What youll bring to the role

Masters Degree in Science or Pharmacy or MBA Successfully completed Bachelor Degree of information management, IT or business administration or an equivalent education
Excellent understanding of generic pharmaceutical development organization and processes
Min 10 years of experience in relevant area
Experience in IT project management and change management IT application management/system management
Knowledge of 21 CFR Part 11 and MHRA data integrity requirements is critical
Knowledgeable about Good Laboratory practice (GLPs), Data Integrity and relevant industry standards to ensure activities are in compliance at all times
Active command in English with excellent written and spoken communication skills

Division SANDOZ

Business Unit Product Dev SZ

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Project Leader/ Project Manager
Salary : As per Industry Standards
Deadline : 20th May 2020

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