Change Control Specialist

**Summary**:
Responsible for the coordination of the Change Control activities, assuring that the process adheres to the Novartis QM directives, Global SOPs, Health Authorities requirements. Manages and follows assigned Change Control projects from initiation (when applicable), until completion, to ensure timely supply to the markets in compliance with regulatory and cGMP requirements

**About the Role**:
**Major accountabilities**:

- Coordinate Change Control activities for Americas region.
- Request input from local functions and ensure that specific information is available in Change Controls and in relevant databases.
- Actively participate in the decision-making process whether a change has impact to Country Organizations or not.
- Generate and analyze predefined and ad-hoc reports in the electronic Change Control system to ensure appropriate execution of services deliverables.
- Drive and coordinate evaluation, execution, authorization, and implementation phases of change requests, considering the most effective implementation strategy, cGMP’s, regulatory requirements, Corporate Quality Manual, Novartis polices and cost effectiveness.
- Facilitate meetings with the experts and stakeholders of the change request to determine & agree required activities and timelines.
- Communicate CR Plan progress, delays and perform escalations as appropriate, in collab-oration with project leader.
- Set priorities for change requests.
- Report changes emerged from the divisions which affects other sites, other BU or authorized third parties for the corresponding impact assessment.
- Initiating Changes by Country Organization that are Managed by NTO/ Global Functions
- Managing country assessments and local implementations in changes from NTO/Global Functions
- Super user in electronic Change Control platform
- Set and provide input on priorities for owned activities.
- Demonstrate customer-oriented service mindset in handling and executing deliverables.
- Responsible for data compilation and preparation of dashboard on a regular basis to track and report deliverables.
- Regularly communicate with customers and partners to collect feedback on support services.
- Responsible for writing and updating SOP’s applicable to owned activities.
- Follow-up on the actions determined by audits, Self-Inspection, Quality Manual, etc.
- Report and record Issues, Deviations, Quality Events emerging from Service delivered.
- Ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for flawless follow-up on activities under scope. Communicate progress and deviations as appropriate in collaboration with team leader.
- Build and maintain high expertise and continuously acquire process knowledge.
- Support and participation in the implementation and modification of the support provided.

**Key performance indicators**:

- Processes under scope KPIs and KQIs.
- High customer satisfaction/responsiveness (no customer complaints).
- Adherence to projects timelines and proactive management of upcoming issues.
- Generation / delivery of reports related to owned activities.
- No issues due to non-observance of cGMP, SOPs and no critical deviations/findings.

**Minimum Requirements**:
**Work Experience**:

- Professional related to Chemical-Biological areas: IF, IQ, IQI, IBT, IB, QFI, QFB, QBP, LF or Project Management with Pharma experience.

**Skills**:

- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.

**Languages**:

- English.

Division

Operations

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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