Senior IT Compliance Specialist
2 months ago
At Lifelancer, we are committed to providing a platform that connects talented individuals with exciting opportunities in the Life Sciences, Pharma, and IT industries.
We are currently seeking a highly skilled Senior IT Compliance Specialist to join our team. This is an excellent opportunity for a seasoned professional to take on a challenging role and contribute to the growth of our organization.
About the Job:
The Senior IT Compliance Specialist will be responsible for managing and performing audits with a focus on Computer System Validation (CSV) audits. The ideal candidate will have several years of experience in the IT industry, preferably in Quality Assurance for Manufacturing, Pharmacovigilance, and Clinical Development, as well as Computerised System Validation and Data Integrity.
The successful candidate will also have expert knowledge and experience in relevant regulations and guidance documents, such as those related to CSV, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Devices, IMP management, Regulatory Affairs, and Pharmacovigilance.
Responsibilities:
- Schedule and manage audits: Develop, maintain, and provide input to an adequate audit plan for global, regional, and local computerized systems and compliance processes. Select and manage qualified service providers for Global Quality, e.g., contract auditors.
- Audit planning and execution: Plan, supervise, conduct, and support internal and external GxP audits. Follow-up on the development, implementation, and completion of corrective and preventive actions with internal and external auditees.
- Support inspections: Coordinate/support the preparation for GxP inspections. Coordinate/support the responses to Regulatory Authorities. Supervise and provide input to the corrective and preventive actions. Follow-up on the development, implementation, and completion of corrective and preventive actions with the inspected Functional Areas.
- Maintain quality documentation: Ensure the establishment and maintenance of required Quality documentation. Ensure appropriate quality standards are adhered to in the management of this documentation.
- Regulatory intelligence: Maintain an overview over relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment. Provide guidance for timely adaptation of Otsuka's procedures.
- Project liaison: Act as quality liaison for assigned projects. Provide sound advice and interpretations related to current GxP guidelines and regulations on CSV Data Integrity to Senior Management and Otsuka employees.
Requirements:
- Degree: Degree in natural science or equivalent business experience.
- Experience: Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, and Clinical Development and Computerised System Validation and Data Integrity.
- Expertise: Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs, and Pharmacovigilance.
- Auditing experience: Experience as a Lead Auditor on internal audits and external vendor audits.
- GxP-related CSV audits: Experienced in GxP related CSV audits and inspections.
- Computerised system validation: Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development.
Benefits:
- Competitive salary: €120,000 - €150,000 per annum (dependent on experience).
- Flexible working practice: Flexible working hours, remote work opportunities.
- Ongoing training: Opportunities for professional development and growth in an inclusive and equitable workplace.
- Comprehensive benefits package: Comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
About us:
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with exciting opportunities in these industries. If you are passionate about making a difference in the life sciences sector, apply now to become part of our team
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