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QA Auditor II/III/Compliance Manager (South Africa)

Pharmaceutical Product Development (PPD)

South Africa

Submission for the position: QA Auditor II/III/Compliance Manager (South Africa) - (Job Number: 185225)

GCP Quality Assurance Auditor II/III/Compliance Manager - Government Consulting(Home-Based)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining atruly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our collea gues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a QA Auditor/Compliance Manager, you will conductcomplex internal and external audits a nd pre-/mock-inspections to ensure compliance with establishedquality assurance processes, standards, global regulatory guidelines and client contractual obligations.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.  

Summarized Purpose:

Conducts complex internal and/or external audits and pre-/mock-inspections to ensure compliance with established processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document rev iews and other GCP/GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, site audits, laboratory and file audits for clients and projects.

GCP Quality Assurance Auditor II/III/Compliance Manager - Government Consulting(Home-Based)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining atruly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our collea gues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a QA Auditor/Compliance Manager, you will conductcomplex internal and external audits a nd pre-/mock-inspections to ensure compliance with establishedquality assurance processes, standards, global regulatory guidelines and client contractual obligations.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.  

Summarized Purpose:

Conducts complex internal and/or external audits and pre-/mock-inspections to ensure compliance with established processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document rev iews and other GCP/GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, site audits, laboratory and file audits for clients and projects.

Essential Functions:    Conducts and/or leads a variety of client or, internal or GCP/GxP audits/activities and hosts regulatory inspections as requested by senior management Performs routine/directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audits Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) Serves as a resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings Experience with FDA regulations and ICH E6 guidelines required, US Government (NIH, DAIDS, BARDA, ARMY) GCP experience desirable.

PPD Defining Principles: 

We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

Essential Functions:    Conducts and/or leads a variety of client or, internal or GCP/GxP audits/activities and hosts regulatory inspections as requested by senior management Performs routine/directed site audits, facility, vendor and/or sub-contractor audits Provides GCP/GxP consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audits Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) Serves as a resources to operational departments on audit or quality assurance subject matter Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings Experience with FDA regulations and ICH E6 guidelines required, US Government (NIH, DAIDS, BARDA, ARMY) GCP experience desirable.

PPD Defining Principles: 

We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD  

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.  

Submission for the position: QA Auditor II/III/Compliance Manager (South Africa) - (Job Number: 185225)

Job posted: 2021-03-01

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