Senior Quality Assurance Pharmacist

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That’s what makes us Roche.

KEY CHALLENGES:

Quality System Management

• Develop and implement quality assurance policies, procedures, and guidelines.
• Conduct internal and external audits to ensure compliance and identify improvements.
• Manage deviations, investigations, CAPA processes, and product quality complaints.
• Provide technical support to the Quality team and oversee document control and risk assessment processes.

Release Management

• Conduct the release of commercial product batches by reviewing compliance with regulations, Roche guidelines and the marketing authorization, according to SOP and required KPI’s.

Contract Management

• Oversee warehouse and distribution providers to ensure compliance with quality standards, implement SOPs, and address any areas of concern.
• Integrate Quality Risk Management into routine processes and conduct annual evaluations to analyze and mitigate risks with Roche affiliates and third-party suppliers.
• Schedule and manage quality audits of GMP and GDP third-party suppliers, compile audit reports, and resolve quality and risk issues as per the annual plan.
• Ensure supplier quality agreements with GMP and GDP third-party service providers are in place, maintained, and updated regularly according to SOPs.

Stakeholder Engagement

• Liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in quality standards and procedure requirements.

A full job description is available upon request.

Please refer the Job description for details