Ani Bagramian

– Quality documentation management: – Update, review, and creation of quality documents (procedures, work instructions, templates, forms) – Preparation of document change records, approvals, and documentation status reports – Change control management: – Coordination of change control activities including initiation, impact and risk assessments, approvals, and implementation tracking – Maintenance of change tracking logs and preparation of summary reports – Non-conformance & CAPA management: – Monitoring, investigation, and follow-up of non-conformances including root cause analysis – Development, implementation, and tracking of CAPAs, including effectiveness verification and closure – Audit support: – Participation in planning, coordination, conduct, and follow-up of internal and third-party audits

– CAPA review : Follow-up with CAPA owners, coordinate implementation of the actions, update and maintain CAPA database documentation

– Volunteer Quality Assurance Consultant at Foldink Biotech, an Armenian startup specializing in 3D bioprinting technology, as part of the Birthright Armenia volunteer program. – Main responsibilities: document control, process mapping, and QMS establishment.

– Change control management: – Review, approval, verification, and impact analysis of change requests related to the QMS – Coordination of impact analysis of change requests related to the product – QMS documentation management: – Ensure proper application of document control rules – Document publication and archiving – User support and training on the Electronic Document Management System (EDMS) – Non-conformity management support: – Root cause investigation (5W) – Coordination of resolution activities – Continuous improvement and regulatory compliance project management

– Data migration to a new Laboratory Information Management System (LIMS): – Analysis of work instructions – Extraction of analytical method parameters – Configuration of specifications and implementation of sampling plans in the new system

– Routine bacterial endotoxin quantification testing: – Test planning – Sample tracking, reception and storage – Test execution according to applicable instructions – Data recording and trend monitoring – Depyrogenation of reusable equipment – Laboratory equipment management – Change Control management – Redefinition of bacterial endotoxin test groups – Reusable equipment depyrogenation process validation: – Risk analysis related to the process (PFMEA) – Development of validation strategy and activity planning – Coordination with subcontractors and scheduling of interventions – Experimental validation activities – Drafting of validation documentation (plan, protocol, report)

– Change Control management – Cleanroom workstation cleaning product replacement: – Identification of impacts and updates to documentation: Work Instructions, General Procedures, Cleaning Records, Cleaning Service Provider Specifications, etc – Development and execution of a protocol to ensure validation of cleanroom workstation cleaning – Standards analysis / Gap analysis: ISO 17664-1 : 2021, ISO 17664-2 : 2021, NF EN 17141: 2020

– Update and creation of QMS documents (work instructions and procedures) – Microbiological contamination control in production environment: – Risk analysis of product biocontamination from the production environment: identification of microbial sources and contamination pathways – Design of an environmental monitoring plan for cleanroom (controlled atmosphere) areas – Update and deployment of the pest control prevention plan – Initial qualification of cleanroom: Co-development and validation of the test protocol