Project Manager Pharm| Telecom |IT

7/2021 – 4/2022

Kusum group (Pharma company, India/Ukraine)
Internal projects: SW Validation, Doc&Workflow
Validation of a computerized pharmacovigilance system according to GAMP5 standards, EU GMP Annex 11. DocFlow Implementation.

SW Validation:
• Alignment of standard operating procedures with relevant business units
• Development of a validation plan, approval of validation procedures
• Coordination of activities of Software Provider within the process framework
• Filling out forms of documents in accordance with EU GMP Annex 11 and applicable SOPs
• Execution of validation activities (testing)
• Collection of project artifacts, printing, signatures, archiving of documents

General responsibilities:
• Determining criteria for choosing solution provider, conducting internal tender, defining technical and business tasks
• Management of internal projects of the company – document flow, specialized software
• Drawing up a preliminary plan for the implementation of the project
• Formation of the project schedule, updating and control of its implementation both within the project team and with the customer
• Fulfillment of AGILE methodology prescriptions
• Regular reporting to the customer on current progress and results achieved during the project, discussion of problematic issues
• Timely and prompt support of the key points of the project with formal documentation
• Setting goals, managing priorities, and monitoring implementation of project tasks by project team experts
• Risk management and conflict resolution
• Formation of the customer's clear understanding of the relationship between software functionality and design work aligned on expected business results
• Ensuring the project implementation terms are agreed with the customer

Adaptive Software Development (ASD), Enterprise project management (EPM), Prozessvalidierung

12/2017 – 12/2020

Eco-monitoring (project volume: 2mln euros), Cybersecurity SW, Infrastructure, IoT (average bill of the project: 60K euros)
Full cycle of project management
• Presale’s activities
Identifying customer needs. Coordination and formalization of initial data, approval of technical specifications, obtaining quotes from suppliers, negotiating discounts and payment terms, equipment supply, coordination of contractors.
• Formation of tender proposals
• Project team management
Setting goals and objectives for the project team, tasks coordinating. Control over the implementation within the schedule and deadlines. Project documentation and reporting
• Contractor management
Supplier cooperation, contract, and document management

Telekommunikation / Netzwerke (allg.)

3/2015 – 12/2018

Management and coordination of the interaction of the work of 50 contractors (FTE’s)
• Contract support of transactions (Purchase Orders, Acts)
• Coordination of contractual activities of the company
• Development of contracts, supplementary agreements to contracts and other contractual documents. Coordination of the document with responsible persons
• Verification and control of information data
• Procedure for signing, printing and sending documents. control of their return. Archiving.

Telekommunikation / Netzwerke (allg.)