Change Control Specialist – Quality Operations

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.