API Manufacturing and Quality Assurance Expert

Expertise

• Active Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.
• Steroid plant operations; training, FDA inspections, and manufacturing.
• Lean management in API manufacturing.
• Quality assurance management; release operations in packaging processes
• API manufacturing - steroids and norsteroids.
• Pharmaceutical products scale-ups and technology transfers.
• Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities, IQ, OQ, and PQ.
• Process and cleaning validations.
• Change control, User Requirements (URS).
• Deviation, Root-cause analyses (fish-bone diagram), CAPA
• FDA inspections without 483's, preparing and presentation of manufacturing areas and the required documentations.
• GMP and EHS audits.
• Quality assurance release operations.
• Product quality Review, training of employee, internal GMP audits.
• Direct QP's (Qualified Person) QA (Quality Assurance) reviewers for release operations.
• Quality assurance consulting at injection and infusion plants.

Experience

Undisclosed Company, GMP Consultant, 2015 - Present

• Qualification of equipment, utilities and facilities.
• Introduction of new GMP training program for employee.
• Batch records, SOP, job descriptions review.
• Overview of personnel to FDA responses.

Mylan Hungary Ltd., Komarom, Hungary, Quality Assurance Manager - Release Operations, 2015

• QA Manager Release Operations of tablets packaging processes.
• Directed 5 QP's and 23 QA reviewers employee.

Gedeon Richter Pharma Plc., Budapest-Dorog, Hungary, Head of API Steroid Plant, 1993 - 2014

• API manufacturing of steroids and norsteroids.
• 7 FDA inspections without 483's.
• The Steroid Plant did not receive any fines or warnings from the government authorities.
• Yearly GMP audits from Health Authorities (inclusive FDA) and from costumers.
• Prepared check-list for each department of Steroid Plant before inspections and audits.
• More than 50 scale-ups and technology transfers (hydrogenation -Birch reduction, ethynilization, oxidation - Jones, Grignard, acylation, different crystallizations etc.)
• Qualification of equipment, facilities and utilities, process water-system, nitrogen-system.
• Process and cleaning validation.
• Change-control, investigation of deviations, root-cause analyses, and CAPA.
• Directed about 120 reports (100 indirect).
• Active member of management, the last 9 years.
• New project for charging of steroids, total closed-system.
• Introduced a new closed-system for clarification step in crystallization procedure.
• Directed the rebuilding of cleaning areas, class "D."
• Used the distilled solvents not just for recovery, as cooling agent.
• Reduced the emission of solvents.
• Introduced a new closed-equipment for cleaning of filters and new cleaning validation.
• Increased the number of batches, using in parallel IQ, and OQ conform equipment.
• Reorganized the warehouse of Steroid Plant.
• The Steroid Plant worked continuously, 24/7, the production increased.
• Decreased the workforce fluctuation.
• Special training for operators before starting a new, scale-up technology.
• Using the lean management at API manufacturing.
• As internal GMP auditor reviewed other departments auditing.

PROFESSIONAL SERVICES

Strategy

• Developed and executed technology modernization concepts and strategies.
• Prepared check-lists for each department of Steroid Plant before inspections and audits.
• Directed more than 100 employees to complete the production expectations according to cGMP and environmental requirements.
• Directed QP's and 23 QA reviewers for release.
• QA Consulting at Injection and Infusion Plants of Teva Hungary Ltd.

Leadership

• Oversee over 20 direct reports and over 100 indirect reports.
• Active senior member in management of 9 years.

Project Management

• Responsible for managing more than 50 technologies update, scale-up, technology transfer projects.
• Executed several cGMP and environmental standardization project, with successful certification, on time and without correction or addition.

Results Oriented

• Practiced at Steroid API's Plant.
• Charging of steroids, and total closed-system.
• Introduced a new closed-system for clarification step in crystallization procedure.
• Managed the scale-up productions without any breakdown.
• Directed the rebuilding of cleaning areas, class "D."
• Used the distilled solvents not just for recovery, as cooling agent.
• Reduced the emission of solvents.
• Introduced a new closed-equipment for cleaning of filters, new cleaning validation.
• Increased the number of batches, using in parallel IQ, OQ conform equipment.
• Reorganized the warehouse of Steroid Plant.
• Development of the human resources management system.
• Introduced an optimized, uniform HR system on time.
• The Steroid Plant worked continuously, 24/7, the production increased.
• Decreased workforce fluctuation.
• Special training for operators before starting a new, scale-up technology.
• Organize the release operations of packaging at Mylan Hungary Ltd. and the 3rd Parties.
• Business performance improvement (BPI) project.
• Ensured a clear understanding of mission and strategy at every level of the plant.
• Redesigned the plant structure in line with the needs of the key and new processes.
• Using the lean management at API manufacturing.

Qualifications and Validations

• Directed and approved the user requirements (URS) and the qualifications (DQ, IQ, and OQ, PQ) of facilities, utilities, equipment (reactors, centrifuges, filter-dryers, etc.)
• Reviewed and approved the validation master plan, validation of analytical methods for intermediates, process and cleaning validation protocols, reports, and validation summary reports.
• Decided with colleagues from QA about revalidations, during the investigation (using fishbone diagram) had to find the root-cause and the corrective actions.
• Batch records reviewing, investigation of deviations, review of job descriptions, consulting and guidance for requalification of facilities and equipment according cGMP rules, helping the personnel for answering to FDA.

Honors & Publications

Credentials

• MS Office
• Internal GMP Auditing Training
• Internal Environmental Auditing Training
• Internal Auditing ISO 9001:2008
• Internal Auditing ISO 9004:2009
• Internal Auditing ISO 19011:2011
• Lean management

Languages

• English (fluent), Romanian (fluent)
• Hungarian (fluent)
• German (elementary)
• French, (Speaking-fluent, conversation, writing)
• Russian; (Speaking-fluent, conversation, writing)

Academic and Professional Affiliations

• Member of Hungarian Excursion Society
• Member of Hungarian Chemical Organization (MKE)

Publications and Patents

• 15 publication from scale-up and technology transfers
• Over 50 international conference, training participation.
• 1 patent

Education

• MSc. Chemical Engineering, "Babes-Bolyai" University Chemical Technology, Cluj-Napoca Romania