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NOVARTIS

Global QMS RDQ Specialist

4-7 Years
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Job Description

Job description

  • As an experienced specialist drive efficiency and productivity gains through contributing to the implementation of new processes to administer a validated Global Learning Manage-ment System (LMS) covering multiple GxP areas in full alignment with Development and QA business goals and strategic objectives.
  • Management of GDD GxP Training content in LMS achieving full regulatory training compli-ance and support as SOP manager for DMS.

About the Role

Key Responsibilities:

  • Manage user accounts for global Development Global Learning Management System (LMS)
  • Release training assignments in the LMS based on applicability s in STAR
  • Update STAR and LMS as per LF Request (Applicability s Change Request process)
  • Training systems document maintenance
  • New/Remove/Update Roles in STAR and LMS
  • Provide technical or administrative support for users
  • Maintain access to LFRC and LFAR upon request
  • Adhere to the global LMS Admin guidelines
  • Ensure harmonization of LMS usage in global Development
  • Perform validation activities - Validation Report, QC of releases, etc
  • Brings up in a timely manner any Level 2 issues related to the LMS
  • Be a role model for the Novartis values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization
  • Seek and implement opportunities for improving efficiency and effectiveness in our training system .
  • Support DMS and 1-DMT in the role of SOP manager

Essential Requirement:

  • Significant relevant work experience (> 5 years) in the pharmaceutical industry or public health sector, in the area of Quality, Human Resources or Training.
  • Demonstrated knowledge in implementing/managing robust Document management systems and Learning Management Systems, setting global quality controls in a regulated area
  • Sound understanding of regulated activities, health authority expectations, and GxP, paired with good business understanding.
  • Role model for the Novartis values and behaviours and exemplary interpersonal skills
  • Excellent leadership, interpersonal, communication, negotiation and problem solving skills
  • Ability to innovative when faced with opportunities or challenges.
  • Ability to influence and drive/facilitate change across the organization.

Desirable Requirement:

  • Bachelor/Technical degree in Life Sciences or related fields.
  • Advanced degree and/or MBA an advantage

More Info

Job Type:
Employment Type:
Open to candidates from:
Indian

About Company

Job ID: 107714473

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