Quality Analyst - Data Integrity Exp. in Pharma Needed from Alpha Consulting Corp. Irvine, CA 92612
QUALITY ANALYST - DATA INTEGRITY EXP.
IN PHARMA NEEDEDIRVINE, CA Project Description:
This role is responsible for supporting the Biologics Quality Risk Management (QRM),Data Integrity (DI) programs utilized by Drug Substances Operations.
In addition, this role will be involved in Internal audit management, Regulatory body audits, and corporate audits.
This role will also plan and execute Compliance readiness plan as needed.
The scope of this responsibility includes DSO Facilities (BSL and BLI) and support organizations (GPT, Engineering, EH&S, etc.
)This role will act as the liaison between DSO and Global Quality Organizations to assure compliance to company policy and support site inspections.
This position assures DSO (BSL and BLI) meets worldwide MOH cGMP regulatory requirements for Quality Risk Management (QRM) and Data Integrity (DI).
Responsible for oversight and support of the Quality Risk management and Data Integrity compliance programs throughout the Client's Drug Substance Organization (DSO), including GMP support functionsThese activities include internal and external compliance systems, GMP, GCP and GLP evaluation, and managing corporate driven initiatives to assure DSO compliance and timely completion of projects.
This position assists in the management of Quality Risk Management (QRM) and Data Integrity (DI) activities, updates procedures to meet corporate and cGMP requirements, and ensure closure of required records.
This position assists in providing on-going QRM and DI training to DSO employees.
This position supports continuous improvement activities within the DSO and assure compliance with all cGMP requirements.
This role will be involved in the implementation of the Internal audit program at DSO and Regulatory and corporate audits.
This role will also plan and execute Compliance readiness plan as needed.
Data Integrity:
Responsible for working with Business Technology for the creation and management of GMP Electronic System Data Lifecycle Management activities such as:
Data Backup and Restore, Data Archiving and Migration.
Ensure Electronic System availability by assuring performance of User Account ProvisioningDeprovisioning, User Access Periodic Reviews, Disaster Recovery Testing, and if needed, System Recovery.
Provide subject matter expertise for change controls for data integrity, OS UpdatesPatches, electronic systems requirements and data security.
Maintain an Electronic Systems Administrator program to comply with the requirements of the FDA, EU and ISO 13485:
2003, and other relevant regulatory bodies.
Provide Electronic System Compliance expertise in for the revision of the Client's DI standards and to provide recommendations regarding DI training materialsElectronic System Compliance & GovernanceAudit Trail Management & Review.
Electronic System Inventory ManagementSupport New Projects (Electronic Systems) Quality Risk Management:
Responsible for building teams, providing training and on-going guidance of employees.
Create templates, procedures, assessments, protocols and other documentation for the QRM program.
This position works with the Client's Corporate to assure appropriate resources are available and guidance's are implemented at the site level.
This position provides hands on support throughout the organization to assures QRM activities are actively monitored, actions completed, and periodically re-evaluated.
This role will work directly in the GMP and non-GMP databases used to support the QRM and DI activities.
This role is required to be proficient in the use of the databases and train and support DSO employees using the systems.
Databases include, but are not limited to, Document Management, Trackwise, Training, Microsoft Office.
Compliance planning and execution:
This role will design and implement a plan to ensure complete compliance to cGMP and all regulatory requirements.
The plan will ensure audit readiness and successful MOH outcomes for licensure for non-commercial site and inspection readiness for commercial site.
Other functions:
Provide support, expertise, and direction to the Client's Biologics sites during regulatory audits and inspection.
Develop strategies to ensure successful audit and inspection outcomes for QRM and DI.
Provide SME input in terms of RCA, CAPA and Investigations.
The employee must conduct their work activities in compliance with all the Client's internal requirements and with all applicable regulatory requirements.
The Client's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
This role will partner with the DSO manufacturing sites (Bioscience Laboratories Campbell and Bioscience Laboratories Irvine), Global Quality Assurance, Procurement, Engineering and other functions, to establish the required business relationships.
This role will also function as a primary contact for all QRM and DI projects, and thus be required to establish and maintain strong working relationships.
This 12
month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kristine:
kristine@alphaconsulting.
com ALPHA'S REQUIREMENT #21-00805MUST BE ELIGIBLE TO WORK IN THE U.
S.
AS AN HOURLY W2 EMPLOYEE#ZR#LI-KN1.
Estimated Salary: $20 to $28 per hour based on qualifications.
IN PHARMA NEEDEDIRVINE, CA Project Description:
This role is responsible for supporting the Biologics Quality Risk Management (QRM),Data Integrity (DI) programs utilized by Drug Substances Operations.
In addition, this role will be involved in Internal audit management, Regulatory body audits, and corporate audits.
This role will also plan and execute Compliance readiness plan as needed.
The scope of this responsibility includes DSO Facilities (BSL and BLI) and support organizations (GPT, Engineering, EH&S, etc.
)This role will act as the liaison between DSO and Global Quality Organizations to assure compliance to company policy and support site inspections.
This position assures DSO (BSL and BLI) meets worldwide MOH cGMP regulatory requirements for Quality Risk Management (QRM) and Data Integrity (DI).
Responsible for oversight and support of the Quality Risk management and Data Integrity compliance programs throughout the Client's Drug Substance Organization (DSO), including GMP support functionsThese activities include internal and external compliance systems, GMP, GCP and GLP evaluation, and managing corporate driven initiatives to assure DSO compliance and timely completion of projects.
This position assists in the management of Quality Risk Management (QRM) and Data Integrity (DI) activities, updates procedures to meet corporate and cGMP requirements, and ensure closure of required records.
This position assists in providing on-going QRM and DI training to DSO employees.
This position supports continuous improvement activities within the DSO and assure compliance with all cGMP requirements.
This role will be involved in the implementation of the Internal audit program at DSO and Regulatory and corporate audits.
This role will also plan and execute Compliance readiness plan as needed.
Data Integrity:
Responsible for working with Business Technology for the creation and management of GMP Electronic System Data Lifecycle Management activities such as:
Data Backup and Restore, Data Archiving and Migration.
Ensure Electronic System availability by assuring performance of User Account ProvisioningDeprovisioning, User Access Periodic Reviews, Disaster Recovery Testing, and if needed, System Recovery.
Provide subject matter expertise for change controls for data integrity, OS UpdatesPatches, electronic systems requirements and data security.
Maintain an Electronic Systems Administrator program to comply with the requirements of the FDA, EU and ISO 13485:
2003, and other relevant regulatory bodies.
Provide Electronic System Compliance expertise in for the revision of the Client's DI standards and to provide recommendations regarding DI training materialsElectronic System Compliance & GovernanceAudit Trail Management & Review.
Electronic System Inventory ManagementSupport New Projects (Electronic Systems) Quality Risk Management:
Responsible for building teams, providing training and on-going guidance of employees.
Create templates, procedures, assessments, protocols and other documentation for the QRM program.
This position works with the Client's Corporate to assure appropriate resources are available and guidance's are implemented at the site level.
This position provides hands on support throughout the organization to assures QRM activities are actively monitored, actions completed, and periodically re-evaluated.
This role will work directly in the GMP and non-GMP databases used to support the QRM and DI activities.
This role is required to be proficient in the use of the databases and train and support DSO employees using the systems.
Databases include, but are not limited to, Document Management, Trackwise, Training, Microsoft Office.
Compliance planning and execution:
This role will design and implement a plan to ensure complete compliance to cGMP and all regulatory requirements.
The plan will ensure audit readiness and successful MOH outcomes for licensure for non-commercial site and inspection readiness for commercial site.
Other functions:
Provide support, expertise, and direction to the Client's Biologics sites during regulatory audits and inspection.
Develop strategies to ensure successful audit and inspection outcomes for QRM and DI.
Provide SME input in terms of RCA, CAPA and Investigations.
The employee must conduct their work activities in compliance with all the Client's internal requirements and with all applicable regulatory requirements.
The Client's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
This role will partner with the DSO manufacturing sites (Bioscience Laboratories Campbell and Bioscience Laboratories Irvine), Global Quality Assurance, Procurement, Engineering and other functions, to establish the required business relationships.
This role will also function as a primary contact for all QRM and DI projects, and thus be required to establish and maintain strong working relationships.
This 12
month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kristine:
kristine@alphaconsulting.
com ALPHA'S REQUIREMENT #21-00805MUST BE ELIGIBLE TO WORK IN THE U.
S.
AS AN HOURLY W2 EMPLOYEE#ZR#LI-KN1.
Estimated Salary: $20 to $28 per hour based on qualifications.
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