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Change Control Analyst

hace 11 horas

Ciudad de México Novartis A tiempo completo

391534BR

**Change Control Analyst**:
Mexico

**About the role**

Location:#LI#CDMX#Hybrid
About the role:

Main Responsibilities:

- Coordinate Change Control activities with the Novartis Control Quality (NCQ)initiating/owning Change Request
- Facilitate meetings with the experts and partners of the change request to determine the required activities and time-lines. Detail the format of pre-work with the impact of each area
- Initiate change Requests on behalf of NCQ (when applicable) in the platform applicable for the change control Progress, coordinate and supervise the change request activities (i.e., task completion, gate approvals, CR closure, etc.) on continues basis, making sure it adheres to the projected time-lines
- Ensure that the change has been evaluated, performed and implemented taking into account all aspects of quality; validation, registration, continuity of business, etc., until it is closed. Follow-up on the issues, time-line extensions with responsible SMEs
- Regularly connect with customers and partners to collect feedback on support services, report result status and continuously acquire process knowledge
- Report to the Quality Assurance of changes emerged from the divisions which affects other sites, other BU or authorized third parties for the corresponding impact assessment. Provide the vital training to staff applicable to the Change Control process and IT systems
- Follow-up on the actions determined by audits, self-inspection, Manual quality, etc. for the Change Control aspects
- Raise IT tickets for technical issues, registration/deregistration users of the existing Change Control platform. Support NCQ and Global Change Control activities/initiatives. Provide guidance for the Change Control process improvements/simplifications

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**
- Breadth QA in pharmaceutical ind./ biotech
- English Proficiency
- Knowledge of IT Applications & tools Quality Standards Quality Assurance
- 3 Years of experience in similar roles
- Portuguese desireable

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

**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Ciudad de México

**Company/Legal Entity**

NOV CORPORATIVO MEX

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes