MontRose Ventures Inc

Integrating Science, Technology, Engineering, & Coaching

MontRose Ventures Inc. is all about radical innovation to address the effects of the pandemic 2020 and moving forward into the 21st century. Montrose is adept at additional services in support of technology, engineering, and coaching. We believe in the highest form of ethics and offer the best service to each of our clients. Do you view disruption as an opportunity or a threat? Are you satisfied with status quo? Let us disrupt status quo and let us take your business from "good to great" with our available services; improving business performance, eliminating waste and driving radical innovation.

PROJECTS

Co-Leader/Project Manager of Preferred Supplier Selection (PSS) project/strategy.

Revamp selection, qualification and management procedures and processes associated with external manufacturing organizations (CMOs)(Contract Manufacturing Organization). Ensure US FDA (Food and Drug Administration) and EU regulations are in place as well as ISO (International Organization for Standardization) regulations and ICH (International Conference on Harmonisations) guidelines to support manufacture of drug products and drug substance (API) (Active Pharmaceutical Ingredient) Responsible for PSS (Preferred Supplier Selection) team meetings as well developed strategy with Procurement, Quality and CMC (Chemistry Manufacturing Controls). Implementation of a 5 year strategy by creating a preferred supplier relationship with qualified external manufacturing organizations. Responsible for Due Diligence Audits/Technical Assessments of selected external manufacturing organizations (CMOs). Lead auditor of Due Diligence Audit team/Technical Assessment team. Responsible for audit reports.

Project manager for validation of 2 computerized systems for Wyeth R&D facility.

Managed a team of engineers and technicians both internally and externally to complete the projects with a budget of $1.2M for each project. In addition, replicated the process for several computerized systems at a commercial facility. Managed the installation and validation of the systems. Developed specification documents and IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) protocols as well as executed protocols. Managed change control from start to full implementation of all projects. Engineering and Technical Writing skills are critical for this task. Full understanding of the front end and back end operational functions and design of computerized systems enabled specifications to be documented and utilized to create IQ, OQ and PQ protocols. Execution of the qualification protocols require team effort and interdepartmental collaboration. Full understanding of rationale used during the validation efforts are critical in order to defend this to regulatory authorities during inspections.

Project manager for validation of a computerized system installed at a commercial pharmaceutical manufacturing facility.

Managed a team of technical writers, engineers and technicians as well as a budget of $1M. Responsible for installation and validation of the system. In addition, responsible for approving protocols. Managed change control from start to full implementation of the project. Engineering and Technical Writing skills are critical for this task. Full understanding of the front end and back end operational functions and design of computerized systems enabled specifications to be documented and utilized to create IQ, OQ and PQ protocols. Execution of the qualification protocols require team effort and interdepartmental collaboration. Full understanding of rationale used during the validation efforts are critical in order to defend this to regulatory authorities during inspections.

ISO 9000 and ISO 13485 certification

Heather was trained as an Internal Auditor and was part of the team instrumental in rolling out ISO 9000 and ISO 13485 across the company. The QC (Quality Control) laboratory was the primary area she was responsible for ensuring all the QSRs (Quality Systems Regulation) were in place. Heather was responsible for the validation of software used in the laboratory as well as validation of laboratory equipment.