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API Manufacturing and Quality Assurance Expert

Technical Consultant #2335


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
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