QA support of laboratory global validation

Validation CAPA investigations Quality System

Software implementation Project, SAP applications

Implementation Quality GMP system into new built facility.

Process validation (upstream/downstream) sterile production. Filling and Packaging technological lines validation. Delta-V process control system. QA audit

Qualification of Sterile Facility (Building system) Validation of Cold Controlled facility and equipment

Requalification of manufacturing equipment, utilities, technologies. SCADA, BMS development and implementation. Validation of LIMS and SAP modules

Technology transfer. SCADA validation Sterile technology Quality system QA, CAPA, Deviations, SOPs

Implementation SAP Quality modules into QC and manufacturing departments. Implementation Lab Ware LIMS system into QC and biological laboratories. Evaluation of SOPs, work documents, training.

Design and implementation of quality system in pharmaceutical company. Validation of computer systems: Electronic submission eCTDX; TrackWise (five modules); manufacturing execution system, SAP (two modules). Global validation and training for the end users. Configuration of TrackWise (CAPA, Change Control). Utility validation (water systems, solvents). Manufacturing equipment, processes.

Managed implementation and evaluation of quality system into start up medical device company. Was a staff specialist in CAPA, manufacturing program. Participated in certification of new facility in California (South San Francisco).

Development, design and Validation of new medical aerosol drug generation system. Generated functional specification for software development project. Executed GMP certification program.

Supervised two validation projects: LIMS customer application (Sample reference system) and Training control system, coordinated plans, time reviews and project approach. Participated in generation of all validation documents: Validation Master Plan, design and functional specifications, IQ/OQ/PQ test protocols, Risk Assessments, Validation reports and training requirements for end users. Provided consultation in implementation risk assessments activity in quality systems, made reviews of validation documents.

Supervised and managed more than 40 validation projects in manufacturing and process control areas: (Building Management Systems, SCADA, PLCs and DCS), Lab Instrumentation validation. Supervised Validation Document Management System, interaction with regulatory affairs, CAPA and QA. Supported and supervised internal Change Control Procedures; generated and reviewed critical validation SOPs, provided quality audit (internal and external). Participated in the Cleaning Validation supervising team, implementation of electronic batch records. Supervised contracts validation projects: Cold Chain Distribution System (equipment), made quality and statistical reviews. Participated in FDA inspections. Provided consultation for validation SQL*LIMS (core) and LIMS modules in QC departments.

Supervised critically important remediation project in production department, GAP analyses. Implementation of Manufacturing Execution System into production facility, design interface with another computer systems (SAP, LIMS, Documentum). Generated Validation project plans, OQ/PQ test protocols. Supervised small engineering team.

Production validation project (Global Sample Management System), LIMS evaluations (raw materials, sample management, environmental monitoring). Generated all validation documents: project plan, risk assessment, validation report. Created and executed IQ/OQ/PQ protocols. System was installed in 5 sites in USA and two manufacturing sites in Puerto Rico. Supervised temporary quality team. Total budget close to 32 mln$ (including hardware).

Scale up syntheses of bulk pharmaceutical drugs (small molecules), transfer technology from lab to production scale (from 10g up to 100 kg). Developed production and research syntheses of new drugs (three patents USA). Made optimization of processes. Developed new methods purification of solid substances, set up pilot equipment (reactors, filters, dryers). Validation of equipment (chemical reactors, filters, dryers, packaging lines), technological processes, analytical systems, process control systems, utilities (water purification, solvents). Supervised production of two drugs for Phase II/III clinical testing. Performed day to day duties on manufacturing facility. In 2003 manufacturing facility was moved to Sweden. Total sale revenue about 700$mln at 2011.

Supervised production department in joint venture: Institute of Polymer Materials (Ivanovo) and BASF (Germany). Scale up syntheses of low molecular polymers for pharmaceutical purposes (up to 100 kg). Scale up and technology transfer from lab to full manufacturing scale under GMP control. Implementation of europian manufacturing standards into manufacturing. Supervised Cold Chain Supply system. Low molecular polymers (PLGA) were supplied to pharmaceutical facilities in EU and United States for production of DDS (Drug Delivery Systems) as a raw materials.