Quality Management Systems (QMS) Implementation
Change Control, Deviation Management, CAPA, Risk&Root Cause Analysis, continual improvement in strict adherence with ISO, GxP and Six Sigma standards
Data Integrity Program Roll Out
A successful roll out of a Data Integrity Program ensures the accuracy, reliability, and security of data throughout the project lifecycle. With a proven expertise, I facilitate implementation in compliance with Eudralex Vol. 4, FDA 21 CFR Part 11, WHO Annex 5, company specific guidelines, and GDocP standards.
Project Management
Regulatory Compliance, cross-functional collaboration, timeline and milestone management, risk management, resource allocation, quality control/assurance, data and budget management
I offer expert consultation in Good Manufacturing Practices (GMP), Good Documentation Practice (GDocP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP), aligning strictly to FDA/EMA/ICH/OECD guidelines in order to maintain the highest industry standards. I have EU GMP Clean Room experience with classes A-D.
Advisory in Regulatory Practices
Over my track record in the pharmaceutical and biotech industry, I actively took part in inspection readiness programs and GMP audits, representing document and production processes successfully.
Inspection Readiness and GMP Audit proficiency
I have expertise in implementing robust Data Privacy Systems aligned with CIPP/US and EU standards, safeguarding sensitive information and ensuring compliance with data protection regulations for your company.
Data Privacy Systems Implementation
Impactful Process Improvements
Pharmaceutical Consultancy
As a pharmaceutical consultant, I am eligible to provide consultancy services in accordance with the provisions outlined in §75 of the Arzneimittelgesetz (AMG).
With a strong foundation in Six Sigma methodologies, I leverage my expertise to drive impactful process improvements while adhering to the industry standards.
"Mr. Povel's excellent interdisciplinary proficiency in Project Management provided the strategic support to shape the overall portfolio and roadmap for customer functions, enablers, as well as hardware and digital services."
Lucia Pabon Global Portfolio Manager
