Octavian B. Email & Phone Number

• Establish strategic compliance programs in preparation for commercialization (QMS, Computer Systems Validation, Computer Software Assurance, Learning, Vendor / Audit Management, Training Program, Data Integrity / IT Compliance, Cloud Governance, GDPR, Cybersecurity, etc.)• Implement streamlined CSV methodology that utilizes a full “science risk-based” approach to assure a consistent and transparent delivery model from project to project.• Implement IT Systems with GxP impact (enterprise, on premise, or cloud based).• Remediate existing systems to assure compliance with applicable regulations / industry guidelines. Helping larger organizations to:• Augment vendor qualifications / audits (Clinical, Data Management (CROs, CMOs), GxP Cloud Providers/ Software Developers)Managed Services and Consultancy in the following areas:• SaaS Governance / GxP Cloud Compliance, Data Integrity, and Data Management• Ongoing Change Management Support for Regulated Applications and Quality Assurance• Vendor Qualification (Hosted Providers, CRO, CMO, GXP Software Developers)• Audit Readiness and Support, Computer Software Assurance • Incident and CAPA Management • Risk-based Systems Implementations (Computer Systems Validation)• Quality Management Systems / IT Compliance Processes and Procedures

Design and Development of Regulatory Compliance Software Suite for Life Sciences:• Electronic Change Management • Smart Document Management • GxP Assessments • 21 CFR Part 11 Compliance Assessment• Quality Cloud Assurance • True GxP Software Development

Chelsea, Massachusetts, Us

Software product development and client consultancy in the following areas:• Quality Management Systems Implementation• Risk Management Programs• Software Compliance and Security Management• Program Management• Consent Decree Management• Audit Management• Training• Computer Systems Validation

Paris, France, Fr

• Responsible for the IT Quality, Risk / Change Management, Computer Systems Validation, Information Security and Compliance functions• Develop and oversee the IT Compliance and SaaS Governance program across various Information Solutions groups (Pharmacovigilance, Clinical, R&D and Medicals Affairs) • Oversee the development and execution of Retrospective Evaluation, Gap Assessments and Remediation activities for GxP IT Systems• Responsible for SOX, HIPAA, Information Security and GxP Audits• Represent IT Compliance and Software Assurance in internal, external and FDA audits

Paris, France, Fr

• Oversee the Validation of Computer Systems for Manufacturing and Labs • Implementation of the first ePedigree and Track and Trace (Serialization) Program• Conduct Vendor Audits (Enterprise IT systems and Applications vendors)• Author guidance documents (SOPs and Policy documents)• Represent IT Compliance on cross functional teams

Paris, France, Fr

• Commissioning and Qualification of a full Manufacturing Suite (approximately 5000 I/O points) • Established Technical Content and Validation Methodology (for applications and infrastructure)• Develop structured test plans• Data migration testing• Validation of GxP Systems (Labs, Automated/ Control Systems – i.e Delta V, PLC, etc).• Validation of medical devices and automated manufacturing equipment.

Bs, Electronics And Telecommunications

Business Management Course