QA Compliance Specialist
This is a temporary contractor opportunity at NovartisNovartis touches the lives of a tenth of the world's population.
Every role here, regardless of contract type, makes an impact on human life!Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company.
Click here to learn more about Magnit www.
magnitglobal.
comReady to work with/through Magnit at Novartis? Please read on
Summary:
The QA Compliance Specialist implements robust Quality Systems for AAA Indianapolis considering Novartis and regulatory requirements of the organization.
This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.
Responsibilities:
oSupports the development and oversight of robust quality systems, including both implementation and operation at site level.
oLeads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
oWorks with the management team to implement and execute the Inspection Readiness program; including Novartis Corporate Inspections and Global Health Authority Inspections.
oFacilitates training on all QA Compliance programs.
oSupports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level.
oContributes significantly to the site inspection preparation, program management, response and commitment process.
oAdministers the site training program.
oEscalates high quality risks per procedure and supports agency notifications such as Field Alerts.
oPerforms duties as assigned to ensure compliance to global and local regulations.
oRepresent QA Compliance on project teams and in meetings.
oSupport the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
oAdheres to all GMP requirements.
oOther related duties as assigned.
Requirements:
3
years of relevant experience High school diploma or higher GMP Pay Rate:
$76.
40 - $86.
18health, dental, vision, 401kLocation:
Role will be fully on-siteWhy Novartis?766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying!Imagine the impact you could make here at Novartis!Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion.
As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.
We strive to ensure that we maintain a positive and enriching work environment for all.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at email protected or 1.
862.
778.
5441 Recommended Skills Assessments Business Process Improvement Performance Indicator Program Management Quality Management Regulatory Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
Every role here, regardless of contract type, makes an impact on human life!Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company.
Click here to learn more about Magnit www.
magnitglobal.
comReady to work with/through Magnit at Novartis? Please read on
Summary:
The QA Compliance Specialist implements robust Quality Systems for AAA Indianapolis considering Novartis and regulatory requirements of the organization.
This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.
Responsibilities:
oSupports the development and oversight of robust quality systems, including both implementation and operation at site level.
oLeads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
oWorks with the management team to implement and execute the Inspection Readiness program; including Novartis Corporate Inspections and Global Health Authority Inspections.
oFacilitates training on all QA Compliance programs.
oSupports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level.
oContributes significantly to the site inspection preparation, program management, response and commitment process.
oAdministers the site training program.
oEscalates high quality risks per procedure and supports agency notifications such as Field Alerts.
oPerforms duties as assigned to ensure compliance to global and local regulations.
oRepresent QA Compliance on project teams and in meetings.
oSupport the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
oAdheres to all GMP requirements.
oOther related duties as assigned.
Requirements:
3
years of relevant experience High school diploma or higher GMP Pay Rate:
$76.
40 - $86.
18health, dental, vision, 401kLocation:
Role will be fully on-siteWhy Novartis?766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying!Imagine the impact you could make here at Novartis!Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion.
As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.
We strive to ensure that we maintain a positive and enriching work environment for all.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at email protected or 1.
862.
778.
5441 Recommended Skills Assessments Business Process Improvement Performance Indicator Program Management Quality Management Regulatory Requirements Estimated Salary: $20 to $28 per hour based on qualifications.
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