Senior Quality Assurance Pharmacist

1w1 week ago

Roche

Johannesburg, ZA · Full-time · ZAR 750,000 – ZAR 1,100,000

About this role

Roche fosters diversity, equity and inclusion, representing the communities we serve. Join Roche Pharma as a Senior Quality Assurance Pharmacist passionate about maintaining high-quality standards and ensuring compliance with regulatory requirements. Uphold excellence through rigorous quality management systems, Good Manufacturing and Good Distribution Practices, and the Roche Global Pharma Quality System.

Develop and implement quality assurance policies, procedures, and guidelines while conducting internal and external audits. Manage deviations, investigations, CAPA processes, product quality complaints, and batch releases by reviewing compliance with regulations and Roche guidelines. Provide technical support to the Quality team and oversee document control and risk assessment.

Oversee warehouse and distribution providers, integrate Quality Risk Management into processes, and conduct annual evaluations with affiliates and suppliers. Schedule and manage quality audits of GMP and GDP third-party suppliers, compile reports, and resolve issues. Ensure supplier quality agreements are in place and updated according to SOPs.

Liaise with internal and external stakeholders, providing input on quality standards and building skills in procedure requirements. At Roche, over 100,000 people across 100 countries push back healthcare frontiers as a leading research-focused group. Our success is built on innovation, curiosity, and integrity.

Requirements

Bachelor's degree in Pharmacy
Registered with the SA Pharmacy Council
5-7 years experience as a pharmacist in the pharmaceutical quality assurance environment
Demonstrated evidence of experience in maintaining and upholding rules and SOPs
Experience in quality system management and compliance with GMP and GDP
Knowledge of deviation management, CAPA processes, and batch release procedures
Familiarity with supplier audits and quality risk management

Responsibilities

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
Conduct the release of commercial product batches by reviewing compliance with regulations, Roche guidelines and marketing authorization
Oversee warehouse and distribution providers to ensure compliance with quality standards and implement SOPs
Schedule and manage quality audits of GMP and GDP third-party suppliers and resolve quality issues
Liaise with internal and external stakeholders on quality standards and procedures

Benefits

Fosters diversity, equity and inclusion representing the communities we serve
Embrace individuality and share a passion for exceptional care
Join where every voice matters
Work in a global research-focused healthcare group pushing frontiers of healthcare