Extelligence is an intelligent partner that goes the extra mile. We provide customized information management solutions for major industries. Our team in Prague and Bucharest is working with international companies, transforming, and adding value to their business on a daily basis. We are growing quickly, and we are interested to bring more talented individuals into our team.
Responsibilities & Qualifications:
- Work under direct supervision of Compliance Officer to perform activities in audit, implementation of polices/ procedures and generating compliance reports.
- Monitor, manage and measure adherence to Quality Management System (QMS) requirements.
- Support compliance team to implement and maintain throughout internal audit program that is consistent with the requirements of the contracts. As part of this program, identify the scope/ areas of coverage of the audit, perform frequent audits and require management to make improvements based upon audit findings.
- Support compliance officer in execution of the audit activities associated to contractual and appropriate applicable regulatory requirements. Enable team to be inspection ready and support a culture of sustainable compliance.
- Write response of the audit reports received from client’s Quality Unit or External Agency to include corrective and preventative actions for any identified observations. Assist client and team in implementing corrective and preventive actions.
- Provide support to clients during a Governmental Authority inspection
- Work with the client’s QA & Compliance Team to perform root cause analysis of compliance issues and provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management. Assist program teams in implementing procedures from operations perspective.
- Ensure that training activities to meet business requirements and systems goals fulfil end-user requirements and identify existing or potential issues.
- Fluent English (B2 and above)
- Change Management, Asset Management, Incident Management, Problem Management etc.
- Nonconformance (NC) and Corrective Action and Preventive Action (CAPA)
- System validation as per customer defined GXP requirement (Qualification and
- validation of hardware and software).
- Security Management – Manage, control, and protect assets in compliance with the customer’s Information security policy which includes:
- HR management (Onboarding/Offboarding of resources and access
- Access control and management
- Managed Third Party supplier management.
- 5+ years of experience in auditing and implementing policies/procedures in regulated environment.
- Completed ITIL Foundation.
- Implemented and maintained ISO 27001, ISO 9001 and ISO 20000.
- Good knowledge on GxP requirements including good documentation practice and computer system validation as applicable in life science and Pharma industry.
- Experience to conduct internal audits to measure and assure adherence to established compliance standards.
- Able to perform risk assessment and participates in Corrective and Preventive Action (CAPA)
- Ability to write concisely, to express thoughts clearly, and to develop ideas in a logical sequence.
- Requires interpersonal communication, group facilitation, project coordination / management and good verbal/written communication skills.
- Knowledge of process improvement methodologies and tools, statistical methodologies.
- ITIL Foundation
- ISO 27001, ISO 9001 and ISO 20000
- Remotely in Poland, Spain, Romania, Lithuania
Working with Extelligence:
- We take care of the important things that matter to contractors, for example, we guarantee on-time payment for your work. You will never have to chase us for payment.
- We always seek to have long term relationships with our team and we always seek to offer opportunities to extend cooperation beyond the first contract or project.
- Extelligence is a multicultural team, we have more than 10 different nationalities working with us.
- We also organize events to bring our team together including team building activities and social events.