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Job Requirements of Sr. Quality Specialist:
-
Employment Type:
Contractor
-
Location:
Indianapolis, IN (Onsite)
Do you meet the requirements for this job?
Sr. Quality Specialist
Careers Integrated Resources Inc
Indianapolis, IN (Onsite)
Contractor
Shift Timing: 8am to 5pm, meetings are scheduled in EST, will consider applicants in other time zones in they can work 8-5 EST
This position is remote and will not require travel.
This position requires highspeed internet access and ability to connect to Teams meetings.
Description:
The Computer System Quality Assurance Team provides quality oversight of business enterprise technology within the Pharmaceutical Services Group (PSG) of ***, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, and adherence to PSG QMS systems. We support a global business network across multiple time zones, collaborating with global Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives. We share and implement standard methodologies within our assigned project Product and oversight of PSG corporate technology.
We are seeking an IT centric quality individual with a critical thinking mentality, able to adapt and work with a diverse variety of individuals, demonstrable understanding of corporate technology implementation and operational maintenance for enterprise SAP instances and the associated lifecycle management both for infrastructure and applications. The candidate should utilize a risk-based approach, able to influence and vitally provide clear direction to teams and leadership.
In addition, the qualified individual must possess strong CSV expertise. This includes knowledge and understanding GAMP 5, 21 CRF part 11, EU Annex 11, 21 CFR 820 (QMSR), 21 CFR 210, and 21 CFR 211 while also serving as the quality reviewer and approver of GxP procedures and respective change, deviation, and validation records. This individual will collaborate with System and Business Process Owners to meet business and regulatory requirements that are inclusive of system design, validation, implementation and lifecycle management.
Our desired candidate has a Bachelors Degree, or higher, in Science, Engineering or QA/Regulatory related course of study, has direct pharmaceutical experience (QA, QC, or Regulatory Affairs), and is an effective collaborator who can develop an internal strategic network while working remotely. Prior experience with SAP compliance is strongly preferred. The candidate must have a clear understanding of risk, in computerized systems and be able to communicate actions, compliance gaps, and commitments to respective areas, including senior leadership. 5 years of experience preferred in a simular role.
What You Will Do:
Collaborate with a team of dedicated QA and IT professionals in the provisioning of IT QA expertise to ensure that applications are delivered and maintained to all necessary regulatory standards.
Knowledge, Skills, Abilities
Know the latest on evolving regulatory requirements related to validation, computer systems, and data integrity requirements.
Capable of contributing to a demanding and evolving work environment across multiple time zones.
Influence and collaborate with internal and external team members, build strong relationships in order to achieve goals.
Evaluate and resolve quality and compliance issues for infrastructure and application.
Drive operational excellence.
Strong decision-making capabilities, with the ability to look ahead and see how decisions in the present affect the future.
Learn corporate processes to better collaborate and hold effective, balanced conversations.
Proficient in Microsoft Office Suite
Effective at multi-tasking and responding to shifting priorities.
This position is remote and will not require travel.
This position requires highspeed internet access and ability to connect to Teams meetings.
Description:
The Computer System Quality Assurance Team provides quality oversight of business enterprise technology within the Pharmaceutical Services Group (PSG) of ***, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, and adherence to PSG QMS systems. We support a global business network across multiple time zones, collaborating with global Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives. We share and implement standard methodologies within our assigned project Product and oversight of PSG corporate technology.
We are seeking an IT centric quality individual with a critical thinking mentality, able to adapt and work with a diverse variety of individuals, demonstrable understanding of corporate technology implementation and operational maintenance for enterprise SAP instances and the associated lifecycle management both for infrastructure and applications. The candidate should utilize a risk-based approach, able to influence and vitally provide clear direction to teams and leadership.
In addition, the qualified individual must possess strong CSV expertise. This includes knowledge and understanding GAMP 5, 21 CRF part 11, EU Annex 11, 21 CFR 820 (QMSR), 21 CFR 210, and 21 CFR 211 while also serving as the quality reviewer and approver of GxP procedures and respective change, deviation, and validation records. This individual will collaborate with System and Business Process Owners to meet business and regulatory requirements that are inclusive of system design, validation, implementation and lifecycle management.
Our desired candidate has a Bachelors Degree, or higher, in Science, Engineering or QA/Regulatory related course of study, has direct pharmaceutical experience (QA, QC, or Regulatory Affairs), and is an effective collaborator who can develop an internal strategic network while working remotely. Prior experience with SAP compliance is strongly preferred. The candidate must have a clear understanding of risk, in computerized systems and be able to communicate actions, compliance gaps, and commitments to respective areas, including senior leadership. 5 years of experience preferred in a simular role.
What You Will Do:
Collaborate with a team of dedicated QA and IT professionals in the provisioning of IT QA expertise to ensure that applications are delivered and maintained to all necessary regulatory standards.
Knowledge, Skills, Abilities
Know the latest on evolving regulatory requirements related to validation, computer systems, and data integrity requirements.
Capable of contributing to a demanding and evolving work environment across multiple time zones.
Influence and collaborate with internal and external team members, build strong relationships in order to achieve goals.
Evaluate and resolve quality and compliance issues for infrastructure and application.
Drive operational excellence.
Strong decision-making capabilities, with the ability to look ahead and see how decisions in the present affect the future.
Learn corporate processes to better collaborate and hold effective, balanced conversations.
Proficient in Microsoft Office Suite
Effective at multi-tasking and responding to shifting priorities.
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