Leiter/in - Qualitätsmanagement

Costa Rica

15-20 Jahre Erfahrung

Geburtsdatum:

Staatsangehörigkeit:
costa-ricanisch

40969827

Hochschulstudium

Zeitraum
Abschluss / Fachbereich / Hochschule
Schwerpunkte

01/200604/2009

abgeschlossen

Master of Business Administration
Unternehmensführung, Management

, Costa Rica

MBA Marketing

  • Dokument_Studium_011.pdf

08/199812/2000

abgeschlossen

Licenciatura
Wirtschaftsingenieurwesen

, Costa Rica

Industrial Engineering

01/199508/1998

abgeschlossen

Bachelor of Engineering (BE)
Wirtschaftsingenieurwesen

, Costa Rica

Industrial Engineering

Berufserfahrung

Zeitraum
Tätigkeit / Unternehmen
Aufgaben

03/201110/2017

QUALITY SR. MANAGER, SITE OPERATIONS

, Costa Rica
Referenzen sind auf Anfrage erhältlich

QUALITY SR. MANAGER, SITE OPERATIONS (≈1300 employees)
Responsible for the Quality Management System. Overseeing the compliance status of the Operation. Responsible on managing FDA,Third Party Audits developing best in class Quality Systems. Ability to organize complex work, conduct problem solving, drive change and install a culture of execution. People Management with demonstrated success as a change agent to improve the organization, teams,employee engagement, professional development and satisfaction. Act as the central repository for Quality and Compliance. Act as the Quality Management Representative for the Site.

QUALITY MANAGER, QUALITY MANAGEMENT SYSTEMS / REGULATORY COMPLIANCE (GMP)
Responsible for overseeing the compliance status of the plant´s operation. Manage External and Internal GMP Audits. Act as the central repository of quality and compliance data with responsibility for analyzing and reporting to Staff Management. Supervise the compliance engineering, documentation and batch record areas. Act as the regulatory representative and determine regulatory strategies. Manage the plant´s internal audit program. Manage the documentation control system for the manufacturing plant. Support the investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary. Perform other related duties as required

  • Dokument_Praxis_021.pdf
  • Dokument_Praxis_022.pdf
  • Dokument_Praxis_023.pdf

06/200904/2011

QUALITY MANAGER, SITE OPERATIONS

, Costa Rica
Referenzen sind auf Anfrage erhältlich

QUALITY MANAGER, SITE OPERATIONS (≈500 employees)
Responsible for the Quality Management System. Overseeing the compliance status of the Operation. Responsible on managing FDA, Third Party Audits developing best in class Quality Systems. Ability to organize complex work, conduct problem solving, drive change and install a culture of execution. People Management with demonstrated success as a change agent to improve the organization, teams, employee engagement, professional development and satisfaction. Act as the central repository for Quality and Compliance. Act as the Quality Management Representative for the Site.

04/200006/2009

QUALITY MANAGER, QUALITY MANAGEMENT SYSTEMS / REGULATORY COMPLIANCE (GMP)

, Costa Rica
Referenzen sind auf Anfrage erhältlich

QUALITY MANAGER, QUALITY MANAGEMENT SYSTEMS / REGULATORY COMPLIANCE (GMP) (≈2500 employees)
Responsible for overseeing the compliance status of the plant´s operation. Manage External and Internal GMP Audits. Act as the central repository of quality and compliance data with responsibility for analyzing and reporting to Staff Management. Supervise the compliance engineering, documentation and batch record areas. Act as the regulatory representative and determine regulatory strategies. Manage the plant´s internal audit program. Manage the documentation control system for the manufacturing plant. Support the investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary. Perform other related duties as required.

  • Dokument_Praxis_011.pdf
  • Dokument_Praxis_012.pdf
  • Dokument_Praxis_013.pdf
  • Dokument_Praxis_014.pdf
  • Dokument_Praxis_015.pdf

Sprachkenntnisse

Sprache
Level
Prüfung / Zertifikat
Deutsch
Grundkenntnisse (A1)

Prüfungs-Zertifikat auf Niveau A1

Englisch
Fließend (C1)

Spanisch
Muttersprache

Weitere Fähigkeiten

Kompetenzen
Führerscheine
Interessen, Hobbys, Persönliches

• EXPERIENCE ON MANAGING AUDITS FROM EXTERNAL AGENTS; AS NSAI (NATIONAL STANDARDS AUTHORITY FOR IRELAND), TUV, FDA, ANVISA, KFDA, GHD AND OTHERS
• 6,5 YEARS WITH NO 483S /MAJOR/MINOR OBSERVATIONS.
• STAR AWARD FOR MEETING GOALS 2014 FOR FDA INSPECTION 2014 & 2005 WITH NO OBSERVATIONS.
• DEMONSTRATED SUCCESS EFFECTIVELY LEADING A QUALITY ORGANIZATION, DEVELOP & RETAINS HIGH VALUE EMPLOYEES (ENGAGEMENT, DIVERSITY AND PROFESSIONAL DEVELOPMENT).
• STRONG COMMUNICATION SKILLS.
• EXPERIENCE ON TRANSFERS & START-UPS
• EXPERIENCE ON DIFFERENT PROJECT MANAGEMENT AREAS
• DEVELOPMENT OF NEW TECHNOLOGIES TEST INSPECTIONS AND OTHERS.
• UNIVERSITY PROFESSOR QUALITY COURSES; MASTER DEGREE
• EXPERIENCE KAIZEN EVENTS (SIX SIGMA & LEAN OFFICE/MFG);
• LANGUAGES: FLUENT ENGLISH / SPANISH (TOEIC CERTIFICATION); A2a DEUTSCHE SPRACHE
• COMPUTER SKILLS: WINDOWS AND MICROSOFT ENVIRONMENTS, LOTUS NOTES, INTERNET, VISIO, GENERAL SOFTWARE AND OTHERS.
• TEAM WORK, LEADERSHIP, PEOPLE MANAGEMENT, INTEGRITY, OWNERSHIP, COLLABORATION, ABILITY TO WORK UNDER PRESSURE, RESULTS ORIENTED INDIVIDUAL, QUALITY AND CUSTOMER SERVICE ORIENTED

  • PKW

So geht's