Alora Pharmaceuticals, LLC.
IT Systems Validation Manager
Alora Pharmaceuticals, LLC., Marietta, Georgia, United States, 30064
POSITION OVERVIEW
The Manager, IT Systems Validation is a member of the corporate IT group responsible for implementing, validating, and maintaining laboratory equipment at the Alora sites to ensure quality and regulatory requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11, HIPAA). The sites include Fort Worth, TX and Marietta, GA.
DUTIES AND RESPONSIBILITIES
Travel to Sites 50%
Serve as an application level or system level administrator for laboratory equipment. Responsible for managing the equipment lifecycle including delivery, integration, modification, and maintenance.
Lead the planning, execution, and documentation of laboratory equipment validation activities according to regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11, HIPAA) and corporate policies by developing and maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk Assessments, Requirements, Design/Functional Specifications, IQ/OQ/PQ Protocols, Trace Matrices, and other documentation required for implementing and maintaining laboratory equipment and equipment software.
Coordinate vendor installations and incorporate vendor validation documentation into the validation process.
Perform periodic assessments of previously validated laboratory equipment, highlighting potential compliance risks, and acting proactively to resolve issues.
Evaluate and assign appropriate user roles and privileges for data integrity (where applicable) for laboratory equipment.
Author laboratory equipment administration and security procedures.
Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards.
Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and objectives.
Develop and perform any required remediation effort and associated CAPA plan.
Support quality improvements related to regulatory agency observations and recommendations.
Consult or contribute to other validation projects as needed and time allows.
Perform other duties as required.
EXPERIENCE AND QUALIFICATIONS
Bachelor's degree in Technology or Engineering discipline.
A minimum of 5 years’ experience in laboratory systems in pharmaceutical or related industry.
Position requires strong GMP compliance knowledge including knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 among others.
Position requires knowledge of GxP Computer System Validation (CSV) activities and testing practices within the Pharmaceutical Industry.
Ability to manage multiple projects simultaneously while performing day-to-day activities.
Ability to present technical information to management, employees, and other departments.
Self-motivated team player with exceptional organization, follow-through, time management, and communication skills.
Excellent ability to write, review, edit, and approve technical or technical documentation.
Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management in the company.
Preferred Experience / Skills
Hands-on working knowledge in Laboratory Information Management Systems and Quality Management Systems.
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The Manager, IT Systems Validation is a member of the corporate IT group responsible for implementing, validating, and maintaining laboratory equipment at the Alora sites to ensure quality and regulatory requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11, HIPAA). The sites include Fort Worth, TX and Marietta, GA.
DUTIES AND RESPONSIBILITIES
Travel to Sites 50%
Serve as an application level or system level administrator for laboratory equipment. Responsible for managing the equipment lifecycle including delivery, integration, modification, and maintenance.
Lead the planning, execution, and documentation of laboratory equipment validation activities according to regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11, HIPAA) and corporate policies by developing and maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk Assessments, Requirements, Design/Functional Specifications, IQ/OQ/PQ Protocols, Trace Matrices, and other documentation required for implementing and maintaining laboratory equipment and equipment software.
Coordinate vendor installations and incorporate vendor validation documentation into the validation process.
Perform periodic assessments of previously validated laboratory equipment, highlighting potential compliance risks, and acting proactively to resolve issues.
Evaluate and assign appropriate user roles and privileges for data integrity (where applicable) for laboratory equipment.
Author laboratory equipment administration and security procedures.
Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards.
Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and objectives.
Develop and perform any required remediation effort and associated CAPA plan.
Support quality improvements related to regulatory agency observations and recommendations.
Consult or contribute to other validation projects as needed and time allows.
Perform other duties as required.
EXPERIENCE AND QUALIFICATIONS
Bachelor's degree in Technology or Engineering discipline.
A minimum of 5 years’ experience in laboratory systems in pharmaceutical or related industry.
Position requires strong GMP compliance knowledge including knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 among others.
Position requires knowledge of GxP Computer System Validation (CSV) activities and testing practices within the Pharmaceutical Industry.
Ability to manage multiple projects simultaneously while performing day-to-day activities.
Ability to present technical information to management, employees, and other departments.
Self-motivated team player with exceptional organization, follow-through, time management, and communication skills.
Excellent ability to write, review, edit, and approve technical or technical documentation.
Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management in the company.
Preferred Experience / Skills
Hands-on working knowledge in Laboratory Information Management Systems and Quality Management Systems.
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