Project Magement, ITIL, Risk Management, CSV

Considerable experience with GxP and 21 CFR Part 11 guidelines, in validated environments.Creation of IQ /OQ, PQ and, Validation Strategy (Validation Plan & Master Validation Plan), Test Plan documentation in support of regulatory compliance efforts. DQ and vendor selection, GAMP5, auditing GxP computer systems, auditing suppliers of computer systems for GxP use and Risk assessment in computer validation, RA (Regulatory Affairs), CAPA (Corrective and Preventive Action), NC(Non Conformance) HHE ( Health Hazard Evaluation, )  QMS (Quality Management Systems), internal and external audits ( FDA, supplier audits, customer audits etc.)
Considerable experience in Quality Assurance environment, audit preparations, GAP assessments, QMS, business – IT processes (ISO 20000) within GMP, GDP, GCP and overall GxP.
Quality Management System: life-cycle management and continuous improvement of global and local procedures to ensure current regulatory requirements.
Change Control: Responsible to perform QA activities for QA Systems related change requests.
Training Management: Ensures trainings are assigned according the applicable process.
Training on compliance-related topics (GxP, 21CFR Part11, GAMP5, ).

Excellent understanding of the Software Development Life Cycle (SDLC) and SOPs and GOPs (SME) and IT QA / eCompliance.
Excellent experience with Enterprise Network and (WAN/LAN) and VOIP Implementation and Integration, Saas, Paas)
Data migration, Disaster Recovery, ITIL v3 (ITSM), Business Continuity Planning, Asset Management Solutions and Security environment.
Very Good understanding of ECM and ERP, Document (EMC) related tools and “tailor made” related tools, SAP implementation and validation (Compliance environment).
Very Good understanding of LAN/WAN Infrastructure migrations and acquisitions.

Very Good understanding with auditing of LAN/WAN infrastructure (HW/SW) and MS applications.

Experience Manager/Team Lead: between 5 – 23 people (Global / virtual)