Quality Engineering Validation Specialist
Posted on Sep 18, 2024 by Eurofins USA BioPharma Services
Columbia, MO
Research
Immediate Start
Annual Salary
Full-Time
Job Description
Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities include:
Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports.
Authoring and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment.
Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products.
Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits.
Assist in preparation and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs.
Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
Maintain close communication with key stakeholders and system owners to keep apprised of computer system’s needs, impacts on validation, project validation status and other relevant issues pertaining to validation.
Completes periodic reviews on computerized systems per established procedure.
Performs other related duties as required and directed.
Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities include:
Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports.
Authoring and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment.
Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products.
Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits.
Assist in preparation and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs.
Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
Maintain close communication with key stakeholders and system owners to keep apprised of computer system’s needs, impacts on validation, project validation status and other relevant issues pertaining to validation.
Completes periodic reviews on computerized systems per established procedure.
Performs other related duties as required and directed.
Reference: 201741064
https://jobs.careeraddict.com/post/95396076
Quality Engineering Validation Specialist
Posted on Sep 18, 2024 by Eurofins USA BioPharma Services
Columbia, MO
Research
Immediate Start
Annual Salary
Full-Time
Job Description
Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities include:
Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports.
Authoring and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment.
Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products.
Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits.
Assist in preparation and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs.
Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
Maintain close communication with key stakeholders and system owners to keep apprised of computer system’s needs, impacts on validation, project validation status and other relevant issues pertaining to validation.
Completes periodic reviews on computerized systems per established procedure.
Performs other related duties as required and directed.
Eurofins BPT-Columbia is looking for a Quality Engineering Validation Specialist to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities include:
Responsible for providing guidance and writing, reviewing / approving CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans and Validation Summary Reports.
Authoring and execution of validation protocols, specifications, change controls and/or scripts related to assigned software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment.
Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products.
Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits.
Assist in preparation and maintenance of Quality System support documentation, including, but not limited to, computer system validation SOPs.
Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports. Prepare Validation Plans, IQ, OQ, Validation Summary Reports.
Maintain close communication with key stakeholders and system owners to keep apprised of computer system’s needs, impacts on validation, project validation status and other relevant issues pertaining to validation.
Completes periodic reviews on computerized systems per established procedure.
Performs other related duties as required and directed.
Reference: 201741064
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