Quality Assurance and Quality Control Expert and Auditor

freiberufler Quality Assurance and Quality Control Expert and Auditor  auf freelance.de
DACH-Region
de  |  en  |  sr
auf Anfrage
4125 Riehen
09.01.2021

Kurzvorstellung

In my many years of working as a QA and/or QC Manager in the areas of Drug Product (ink. sterile Manufacturing), API, as well as in the areas of Device Development, I have gained a very broad expertise and experience.

Ich biete

  • Certified Auditor for ISO13485:2016
  • Certified Professional for MedicalSoftware
  • Expert for Computer Validation and PAQ
  • Expert of Pharmaceutical Technology
  • Expert of Qualification
  • Expert of Validation
  • GDP verantwortliche Person nach AM-Handels-V
  • GMP Expert and GMP Lead-Auditor
  • MBA (with focus on Project- and Processmanagement)
  • Technisches Qualitätsmanagement / QS / QA

Projekt‐ & Berufserfahrung

Head of Technical QA
Roche, Basel
1/2015 – 12/2020 (6 Jahre)
Life Sciences
Tätigkeitszeitraum

1/2015 – 12/2020

Tätigkeitsbeschreibung

Head of QA Technics and Service Provider Management within TR&D Basel
• Leading a team of 10 QA Subject Matter Experts in the field of small Molecules and
Biologics for Qualification & Validation activities related to Drug Substance, Drug
Product and Combination Products (ISO13485)
• Leadership for quality oversight of process/cleaning validation, Automation and
Computer validation, Quality Risk Management, Change-Control, CAPA, Discrepancy
Management and Equipment qualification activities in production and analytical areas
• Global Lead for Service Provider and Supplier Qualification in TR&D (300 Companies)
• Execution of more than 70 audits as Lead Auditor in the last 5 years

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA


QA Manager (Main QA responsibility for the Capex Project 150Mio.)
Roche, Kaiseraugst
1/2010 – 1/2015 (5 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

1/2010 – 1/2015

Tätigkeitsbeschreibung

• QA Managing of Combination Products (MDR) including Product Release
• QA Lead and responsibility for two new construction projects in Basel and Kaiseraugst
150 mCHF new facility for Medical Device)
• Managing and providing of QA Subject Matter Expertise for:
• Qualification of Production Equipment (sterile formulations)
including Process Automation according to GAMP5 and CSV activities
• End to End Aseptic Process Validation (Sterilization, Mediafill, CIP/SIP, VHP)
• Facilities zone concept, Critical Utilities (PW, WFI, Steam) incl. Risk-Mgmt.
• Preparation of the departments for Swissmedic GMP-Inspections
° ISO13485 Qualitymanagement from Development to Commerzial

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA


QA Manager (Main QA responsibility for the Capex Project 400Mio.)
Roche, Basel
1/2008 – 1/2014 (6 Jahre, 1 Monat)
Life Sciences
Tätigkeitszeitraum

1/2008 – 1/2014

Tätigkeitsbeschreibung

QA Manager (Main responsible QA) for
TR&D Neubau für alle galenischen Formen (Capex 400 Mio.)

Projektbeschreibung QA Verantwortung (End-to-End) für ein neues Produktionsgebäude für die technische Forschung und Entwicklung in Basel. Leitung eines Teams von 5-8 QA Managern.
Betreuung des Projektes in CD, BD, DD >> IQ,OQ,PQ >> Lieferantenmanagement >> Inspektionsvorberitung und Moderation der Behördenabnahme durch Swissmedic.
Resultate des Projektes: In-Time, In-Budget, GMP-Compliant (ohne Beanstandungen bei der behördlichen Abnahmeinspektion), Gewinner des Facility of the Year Awards in der Kategorie Projektmanagement

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA


Group Lead GMP Compliance Manager in QC Biotech
Roche, Basel
1/2002 – 5/2006 (4 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

1/2002 – 5/2006

Tätigkeitsbeschreibung

Group Lead GMP Compliance Manager in QC Biotech
• Lead the GMP team to implement an improved quality system for QC Biotech.
Approval of all department SOPs as Author or QC Manager.
• Primary responsibility for Qualification, Calibration and Maintenance of Analytical
Equipment, Archiving GMP documentation, Preparations for authority’s inspections

Eingesetzte Qualifikationen

Qualitätssicherungssysteme


Laboratory Head EU Release Analytics
Roche, Grenzach-Wyhlen
1/1995 – 5/2000 (5 Jahre, 5 Monate)
Life Sciences
Tätigkeitszeitraum

1/1995 – 5/2000

Tätigkeitsbeschreibung

Quality Assurance Manager for QC “EU Release”
• Responsible for compliance and further development of the GMP Quality System
• Review and approval of all SOPs, Deviation-/Investigation-Reports, EquipmentQualification-Plans/Reports, Method-Validation, Method-Transfers
• Execution of Self-Inspections and preparations for authority’s inspections
• Member of the QC Leadership-Team

Laboratory Head EU Release Analytics
• Laboratory Head of 7 laboratories within the EU Release Department
• Leading a team of 12 laboratory technicians in the field of Small Molecules and
Biologics QC testing activities related to: Drug Substance and Drug Product
• Plan and manage resources to provide analytical support to Roche Basel HQ
• Managing and providing of QC Subject Matter Expertise for:
• Analytical Method-Development, -Validation and -Transfer (in and out)
• Fully automated analytical systems for HPLC and dissolution testing

Laboratory Head centralized Chromatography
• Laboratory Head of 3 HPLC laboratories
• Leading a team of 5 laboratory technicians in the field of HPLC testing activities for:
Vitamins, small molecules drug products, various Roche Grenzach OTC products
• Executing HPLC Method-Development and Validation.
• Supervisory review and approval of QC results and reports

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA


Ausbildung

Good Quality Practies (GQP)
(2,2)
Jahr: 2020
Ort: Uni Albstadt-Sigmaringen

International Executive MBA
(1.4)
Jahr: 2012
Ort: Salzburg

Chemielaborant
(Ausbildung)
Jahr: 1990
Ort: Rheinfelden

Qualifikationen

Auditing, Automation, Regulatory Compliance, Automation Testing, Beratungs- / Partnering Skills, Chemie Fertigungskontrollen, Erweiterte Fehlerbehebung,
Fertigung / Produktion, Funktionsübergreifende Teamführung, GMP, GMP-Einhaltung,
Herstellungsqualität, ISO13485:2016, ISO9001:2015, Konfliktmanagement, Kosten / Budget Entwicklung & Management, Lagerung, Materialmanagement, Mentoring Fähigkeiten, Methodenentwicklung, Operational Excellence, People Management,
Planning & Forecasting, Produkt Risk Management, Projektmanagement, Qualität,
Qualitätsmanagement, Qualitätsrisikomanagement, Qualitätssicherung / -kontrolle,
Qualitätssicherung (QA), Regulatorische Audits / Inspektionen, Regulatorische Richtlinien,
Risiko- / Sicherheitsmanagement, Schlanke Produktion, Stakeholder-Management,
Standardarbeitsanweisungen (SOP), Supplier Relationship, Entwicklung, System Design,
Systemtechnik, Teamführung, Technische Applikationen Design / Management,
Technische Vorschriften, Technologie Change Management, Testing (Validation & Verification), Validierung, Validierungspläne, Vertragsverhandlungen,

Über mich

In my many years of working as a QA Manager in the areas of Drug Product
(solids and sterile forms), Active Ingredients (API SM) as well as in the areas of
Device Development and QC Analytics (Biotech and SM), I have gained a very
broad expertise and experience. The combination of extensive experience in
many pharmaceutical areas together with my business administration and
process management skills from my MBA Program, allows me to use the
resource QUALITY exactly where it works most efficiently and effectively, without
compromising on GMP-COMPLIANCE.
Outstanding achievements can only be reached when working in a wellfunctioning team. In my role as group leader of 8-10 direct reports, I attached
great importance on an open, respectful and cooperative environment,
challenging and supporting my employees within their responsibilities and
abilities, in line with the company commitments.
I see my strengths also in supporting departments, projects, or external
companies in implementing quality risk management and improving quality
processes, especially in the field of qualification and validation.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Serbisch (Fließend)
  • Kroatisch (Fließend)
Reisebereitschaft
DACH-Region
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
274
Alter
52
Berufserfahrung
31 Jahre und 1 Monat (seit 01/1990)
Projektleitung
5 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden »