Quality Assurance Pharmacist

Job description

  Job facts

Quality Assurance Pharmacist

Location: Illovo

Reports into: Quality Assurance Manager

Who we are

At Roche, more than 95,000 people across 150 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, and on seeing each other's differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

The Position

Make your mark. Improve lives.

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

As a Roche Quality Assurance Pharmacist, you will be ensuring that Roche Products comply with the local and international Quality Assurance standards, safeguarding legal compliance to these and thereby ensuring the quality assurance function in totality.

The QA Pharmacist ensures compliance to quality requirements as prescribed by current Good Manufacturing and Good Distribution Practices and the Roche Global Pharma Quality System.

Amongst other duties your role will entail to:

·  Ensure adherence to the Roche's Pharma Quality system and local South African requirements (SAHPRA and SAPC) when executing quality activities.
·  Maintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations.
·  Release commercial product batches to the local market ensuring compliance with the local regulations, Roche guidelines and the marketing authorization, according to SOP and required KPI's.
·  Ensure that all relevant GMP/GDP processes are described in current Standard Operating procedures and are adhered to correctly.
·  Assist with oversight of outsourced GMP/GDP processes are described in current Standard Operating procedures and are adhered to correctly.
·  Assist with oversight of outsourced GMP/GDP relevant suppliers by ensuring that Quality Agreements are current and audits are performed in accordance with Roche's Pharma Quality system.
·  Perform self – inspections.
·  Handle discrepancies in Discrepancy Management System and according to SOP.
·  Use the change management system to initiate, assess and approve GMP/GDP relevant changes prior to implementation.
·  Handle complaints, recalls and returns according to Pharma Quality System and local SOP's.
·  Compile annual quality product reviews, according to SOP.
·  Action corrective actions, preventative actions and recommendations as per audit reports, self-inspections, discrepancy remediation, complaints remediation to ensure continual improvement.
·  Perform quality risk assessments, establish risk controls and review risks to assist with the Quality Risk management process.
·  Ensure that all GMP related documentation is handled correctly and is readily available.
·  Interact and support the relevant internal and external stakeholders with regards to ensuring quality standards and procedures are met and followed.

Who you area

You, as an ideal candidate , will have the following education, experience and skills:

·  Pharmacy degree (NQF 7) or any related qualification
·  2-3 years' experience as pharmacist in the pharmaceutical quality assurance environment.
·  Demonstrate evidence of maintaining and upholding rules and SOP's.
·  In-depth knowledge of relevant pharmaceutical and medicines legislation.

Skills and Knowledge:

·  Knowledge of relevant pharmaceutical and medicines legislation.
·  Knowledge of GMP/GDP.
·  Knowledge on validation.
·  Knowledge of specific operational processes (SOP's, SLA's)
·  SAP knowledge.
·  Knowledge and understanding of interrelated organisational structures and processes.
·  Roche Product portfolio.
·  Roche Global SOP's and Directives.

Roche is an equal opportunity employer.

The next step is yours. Submit your CV to Lungile Zondi at

Closing date 7 September 2018

Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance

·  Who we are

At Roche, 94,000 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.

Desired profile

Who you area

You, as an ideal candidate , will have the following education, experience and skills:

·  Pharmacy degree (NQF 7) or any related qualification
·  2-3 years' experience as pharmacist in the pharmaceutical quality assurance environment.
·  Demonstrate evidence of maintaining and upholding rules and SOP's.
·  In-depth knowledge of relevant pharmaceutical and medicines legislation.

Skills and Knowledge:

·  Knowledge of relevant pharmaceutical and medicines legislation.
·  Knowledge of GMP/GDP.
·  Knowledge on validation.
·  Knowledge of specific operational processes (SOP's, SLA's)
·  SAP knowledge.
·  Knowledge and understanding of interrelated organisational structures and processes.
·  Roche Product portfolio.
·  Roche Global SOP's and Directives.

Roche is an equal opportunity employer.

The next step is yours. Submit your CV to Lungile Zondi at

Closing date 7 September 2018

Roche is an equal opportunity employer.
Quality, Quality > Quality Assurance

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