Senior Quality Assurance Pharmacist
Locations: Johannesburg, South Africa
Time Type: Tempo integral
Posted on: Publicado ontem
Time left to apply: Data de término: 19 de novembro de 2024 (11 dias restantes para se candidatar)
Job Requisition ID: 202411-128235
A Roche promove a diversidade, a equidade e a inclusão, representando as comunidades que atendemos. Ao lidar com saúde em escala global, a diversidade é um ingrediente essencial para o sucesso. Acreditamos que a inclusão é essencial para entender as diferentes necessidades de saúde. Juntos, abraçamos a individualidade e compartilhamos a paixão por cuidados excepcionais. Junte-se à Roche, onde cada voz é importante.
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 KPIs.
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.
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 experience as a pharmacist in the pharmaceutical quality assurance environment and you have demonstrated evidence of experience in maintaining and upholding rules and SOPs.
About Us
Na Roche 100,000 pessoas em 100 países estão ultrapassando as fronteiras em cuidados com a saúde. Trabalhando juntos, nos tornamos um dos líderes mundiais em grupos de pesquisas. Nosso sucesso é construído com inovação, curiosidade e diversidade.
A Roche é um empregador que pratica políticas de igualdade de oportunidades.
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