GxP Compliance Engineer
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GxP Compliance Engineer
Description de la fonction
The GxP Compliance Engineer will have site responsibility for CSV support in all aspects of systems and programs requiring software qualification and testing to include: evaluation, onboarding, and potential management of external resources to assist in introducing new GxP computer systems used onsite and in the production space, whether on premise or cloud based, as well as be responsible for compliance review of computer systems including process control, and data acquisition for local systems. The GxP Compliance Engineer will mentor and lead compliance and validation staff and supports manufacturing and laboratory management, systems maintenance, trouble shooting and future enhancements.
- Collaborate with IT Corporate organizations, sets requirements for the compliant execution of software validation and equipment/instrument qualification per regulatory expectations.
- Provide oversight for Computerized System Validation such as analytical equipment and electronic systems to maintain a compliant state.
- Write, review and approve user requirement specifications, instrument risk assessments, operations, SOPs related to computerized systems for compliance to regulatory requirements.
- Is a Subject Matter Expert (SME), knowledgeable of industry practices for validation and qualification principles and theories related to computerized systems, CSV audits, quality and regulatory audits in conjunction with QA compliance leaders and system owners.
- Develop computer system compliance strategies, especially for FDA 21 CFR Part 11 and Annex 11 compliance.
- Provides training as required regarding system applications and for personnel performing CSV.
- Responsible for the timely execution of all systems implementations, software validations and equipment/instrument qualifications, in a compliant manner and in alignment with established quality and regulatory requirements.
- Supports and troubleshoots complex investigations related to computerized systems.
- Maintains the computerized validation status as part of validation life cycle.
- Completes periodic reviews on computerized systems per established procedure.
- Oversees the updates and maintenance of computerized systems on routine basis and evaluates new systems for implementation
- Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures.
- Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
- Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
- Review CSV Validation activities including deliverables from regulatory compliance standpoint.
- Provide support to external and internal audits related to computerized system validation activities.
- As required, assist Corporate IT organizations establish and maintain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Assist as needed in audits and inspections.
- Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
- Advise a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines
- Bachelor's degree in life sciences, engineering discipline or equivalent, and a minimum of 5-7 years of relevant biotechnology or pharmaceutical cGMP regulated environment, validation and qualification of equipment and computer systems in a pharmaceutical organization
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5
- Ability to provide guidance on revising validation documents and protocols
- Experience in managing and executing projects
- Ability to work independently with limited managerial oversight.
- Strong interpersonal and organizational skills.
- Possess excellent leadership and project management skills.
- Must be capable of multi-tasking and performing assignments that have loosely defined objectives.
- Ability to effectively communicate verbally and in writing, in both English, Dutch and French.
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