Quality Assurance Associate

Vor 4 Tagen


Zug, Schweiz Panda International Vollzeit

QA Associate

This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting

Coordinate training for Global External Quality teams

Establish and maintain IT tools for executing work to increase effectiveness

Identify and create software solutions for data extraction from different IT systems

Create and maintain a Power BI dashboard for External Quality KPIs

Support new IT system implementation and participate in testing functionality

Serve as a super user for electronic systems such as Veeva and Oracle

Represent the External Quality department as a TOPS Operational Excellence ambassador

Support regulatory inspections as the process owner of the Seagen CMO KPI process

Write and review Standard Operating Procedures as needed

Oversee the Process Improvements projects follow up process in External Quality

Support the implementation of risk management in External Quality

Maintain the quarterly KPI and risk register of CMOs

Provide External quality input to TO’s monthly score card

**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry

Experience in project management and managing global action plans

Good communication skills and proven ability to work well with senior internal and external stakeholders

Experience with electronic documentation management systems preferred

Expertise in Excel, PowerPoint, and other office software

Ability to prioritize work and handle multiple assignments while maintaining a high level of quality

Fluency in English speaking and writing

Education

Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar

Training in computer science and/or automation is desirable

Interested?

QA Associate

This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

**Responsibilities**:
Manage KPI programs for Global Quality Operations and reporting

Coordinate training for Global External Quality teams

Establish and maintain IT tools for executing work to increase effectiveness

Identify and create software solutions for data extraction from different IT systems

Create and maintain a Power BI dashboard for External Quality KPIs

Support new IT system implementation and participate in testing functionality

Serve as a super user for electronic systems such as Veeva and Oracle

Represent the External Quality department as a TOPS Operational Excellence ambassador

Support regulatory inspections as the process owner of the Seagen CMO KPI process

Write and review Standard Operating Procedures as needed

Oversee the Process Improvements projects follow up process in External Quality

Support the implementation of risk management in External Quality

Maintain the quarterly KPI and risk register of CMOs

Provide External quality input to TO’s monthly score card

**Qualifications**:
3+ years of experience in the regulated pharmaceutical industry

Experience in project management and managing global action plans

Good communication skills and proven ability to work well with senior internal and external stakeholders

Experience with electronic documentation management systems preferred

Expertise in Excel, PowerPoint, and other office software

Ability to prioritize work and handle multiple assignments while maintaining a high level of quality

Fluency in English speaking and writing

Education

Master's degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar

Training in computer science and/or automation is desirable

Interested?



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