Senior Consultant

• Jul 2021 - Present

Senior Global Computer System Quality Assurance Manager (external consultant)

• Aug 2021 - Present

Develop, maintain, and continually improve the Global Quality Computer Systems used in the PT network, to ensure uninterrupted supply of products to patients. Through extensive collaboration with business partners, I ensure that GMP systems are built and sustained in a compliant manner consistent with internal and external regulations and expectations.Quality oversight for global PT GMP Computerized Systems (CS), based on a strategic risk-based methodology and framework.Support for the following QA and Manufacturing Systems:>Cloud Based Temperature Monitoring>Regulatory Submission system>Paperless Validation & Qualification>Global Smart Fridge>Global Release Execution System

Senior Validation Lead (external consultant)

• Nov 2019 - Jul 2021

Validation as a Service for the following systems:SAP VaaS Management: full set of planning, execution, monitoring and reporting of all validation activities.- Manufacturing planning, execution and reporting - Quality Management and Quality Control processes - Supply Chain planning, execution and reporting - Finance and Controlling processes - Plant Maintenance planning, execution and reporting - Direct and indirect Procurement and Sourcing processes - Product Lifecycle Management - Waste Management System also supports related Master Data, Change and Document Management processes of Roche Diagnostic`s manufacturing and hub sites. MES - (iTAC) Manufacturing of Blood Gas and Electrolytes 123 SensorsLIMS - (LabVantage) Clinical Information Management (CIM) & Clinical Identification Access Management (C-iAM)Clinical Trial Management System (CTMS)

IT Quality Manager and Project Manager Team Leader

• Jul 2013 - Jul 2021

Provide consulting support and services for Governance, Risk and Compliance for regulated industries.Responsible for a team of 8 Project Quality Management consultants in addition to a full time consulting contract. Provide consulting support and services for Governance, Risk and Compliance for regulated industries.Responsible for a team of 8 Project Quality Management consultants in addition to a full time consulting contract.

Senior Global Computer System Quality Assurance Manager (external consultant)

• Jan 2018 - Jan 2020

Ensured GMP Computer Systems were delivered and maintained in a compliant manner. Established Quality Standards for systems that support manufacturing, testing, release and distribution processes. - Facilitated the Business to deliver safe products to patients- Enabled manufacturing, testing and release of uninterrupted supply to patients CSV, qualification, discrepancy/CAPA Management, and investigation processesto meet strategic quality and business objectives.SAP Advanced Track and Trace for Pharmaceuticals (ATTP), Serialization and Supply ChainRegulatory Submission system

Senior Informatics Specialist – Signal Management Delivery Service Manager (external consultant)

• Jul 2017 - Mar 2018

Operational Management in Safety Risk Management by ensuring:- Releases and changes were applied without interruption of services as per agreed metrics and levels- Service availability as per agreed service levels and provided regular Service reports- Adherence to IT standards (including security, privacy, quality, and process)- Contingency and disaster recovery plans were in place and aligned to business continuity plans where applicable.Also managed:- Change control procedures and processes. This included the management of the change control board (CCB) and oversight of the approved change- Capacity Planning and ensured the correct capabilities were in place- Managed Vendor relationships- Incident, knowledge, problem, change, request and configuration management according to Global IT Processes

SAP Validation Lead (external consultant)

• Jul 2015 - May 2017

Validation Lead for the following SAP Projects:- Global Integrated Artworks and Labeling Management Solution.- ERP Harmonization: Validation and Support Process for Demand-to-Supply organization.- Business Process and ERP Vision (SAP S/4 HANA) - Simplification and harmonization of ERP to create an agile, transparent and efficient Business Model.ERP Validation Core Team Member.ERP Testing Management and Document Management Process Expert.Ensured Audit readiness for a Clinical Drug Supply Application.Conducted 21 CFR Part 11, EudraLex Volume 4 Annex 11 Compliance Assessments.

Litigation and IT Security Manager (external consultant)

• Apr 2015 - Jul 2015

Aligned with Novartis legal in identifying any potential Data Privacy, Litigation or Security issues that would prevent using a cloud based file service solution globally within Novartis. Aligned with Novartis legal in identifying any potential Data Privacy, Litigation or Security issues that would prevent using a cloud based file service solution globally within Novartis.

Project Quality Manager (external consultant)

• Aug 2013 - Dec 2014

Implemented the following for Novartis GIS (IT Infrastructure):- IT Service Classification Process as part of the Control Framework to embed quality, meet compliance requirements and reduce risk. - A new EDMS system. - The Group IGM Policy Framework within GIS.- A Qualified IT platform server solution supporting GxP application data for Near Patient Testing (NPT). Implemented the following for Novartis GIS (IT Infrastructure):- IT Service Classification Process as part of the Control Framework to embed quality, meet compliance requirements and reduce risk. - A new EDMS system. - The Group IGM Policy Framework within GIS.- A Qualified IT platform server solution supporting GxP application data for Near Patient Testing (NPT).

Senior Consultant

• Jul 2006 - May 2012

Provided consulting support and services for regulatory compliance for pharmaceutical and medical device companies. Provided consulting support and services for regulatory compliance for pharmaceutical and medical device companies.

IT Quality Validation Specialist (external consultant)

• Jul 2006 - Dec 2011

Ensured that IT projects were documented and validated in accordance with GSK QMS and Business Risk objectives, all relevant regulatory bodies & GSK IT Security policies. Wrote, reviewed and approved validation documentation and ensured a risk based approach was applied.Ensured all Process Control Systems were always inspection ready.Provided assistance and guidance to others in the production of validation documents and quality/compliance/business risk aspects.Provided guidance on identifying and mitigating both regulatory and business risks and acted as quality representative.

Systems Validation Analyst

• Jun 2004 - Jun 2006

Ensured that the WPS Europe and Asia Pacific region computer systems satisfied the current and future requirements of the FDA and other authorities.Managed the implementation and roll out of a Manufacturing Execution System (MES) at seven manufacturing facilities across the region.Project managed the implementation of business systems such as SAP R/3 and MES in compliance with FDA Predicate Rule / Part 11 requirements.Assisted with the establishment of a master systems validation plan, facilitated remediation actions with system and process owners, and supported and trained system owners and users in the requirements of 21 CFR Part 11.

Validation Engineer

• Apr 2003 - May 2004

Developed the necessary documentation (Validation Master Plans, IQ, OQ and PQ protocols and SOPs) to qualify and validate primary processes supporting the production of sterile products.Used protocols to validate production machines, utilities and ancillary equipment.Ensured compliance of quality-critical software systems to 21 CFR Part 11, EU Annex 11 and GMP.Validated Class 7 and 8 clean rooms and developed environmental monitoring programs for these rooms.Performed internal quality assurance audits, reviewed manufacturing and business processes to ensure compliance with regulatory standards.

Development Engineer

• Apr 2001 - Apr 2003

Evaluated and tested prototypes and products using Picolog, Labview, flow rate monitors and Datatakers.Developed assembly SOPs and work instructions.Performed process capability studies using statistical process control techniques.Managed the production of verification builds at Mechatronic in Germany. Evaluated and tested prototypes and products using Picolog, Labview, flow rate monitors and Datatakers.Developed assembly SOPs and work instructions.Performed process capability studies using statistical process control techniques.Managed the production of verification builds at Mechatronic in Germany.