KrakówKraków, Lesser Poland
- Offer expired 9 days ago
- Remote recruitment
- contract of employment
- specialist (Mid / Regular)
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 HCL 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)
• Documentation Management.
• System validation as per customer defined GXP requirement (Qualification and validation of hardware and software).
• Training management
• 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 terminations)
-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.
What we offer
Private health insurance
Clear career path in a growing multinational organization
HCL is a business enterprise with presence in the fields of technology and healthcare. Founded in 1976 as one of India's original IT garage startups, the HCL enterprise currently comprises three companies in India - HCL Technologies, HCL Infosystems and HCL Healthcare with annual revenues of US$ 6.5 billion and over 95,000 professionals from diverse nationalities operating across 31 countries including over 500 points of presence in India. In the technology space, HCL’s offerings span a wide range of software and hardware services and solutions including R&D, Technology Services, Enterprise and Applications Consulting, Remote Infrastructure Management, IT Hardware, Systems Integration, Distribution of Technology and Telecom Products. A new entrant in Healthcare, HCL aims to provide innovative medical services, products and training to meet the growing demand for quality Healthcare in India.
In Poland we started our operations in 2007. Our operation in Poland primarily revolves around the global technical support centre through which we provide multilingual Infrastructure Management Support to our clients. Apart from providing multilingual technical support in 15 languages, we also work on technology based projects for our clients.