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.
The Opportunity:
Are you passionate about maintaining high-quality standards and ensuring compliance with regulatory requirements? Join our team at Roche Pharma in Johannesburg as we strive to uphold excellence in our products through rigorous quality management systems, adherence to Good Manufacturing and Good Distribution Practices, and the stringent Roche Global Pharma Quality System. Your expertise will be pivotal in shaping and sustaining our commitment to quality, safety, and continuous improvement in the pharmaceutical industry.
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.
Who you are as our ideal candidate:
- You hold a Bachelor’s degree in Pharmacy and you are registered with the SA Pharmacy Council.
- You have gained 5-7 years of experience as a pharmacist in the pharmaceutical quality assurance environment and you have demonstrated evidence of experience in maintaining and upholding rules and SOPs.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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