Senior QA Consultant

freiberufler Senior QA Consultant  auf freelance.de
Referenzen
offline
Verfügbarkeit einsehen
National
de  |  en  |  ru
auf Anfrage
4434 Hölstein
29.08.2018

Kurzvorstellung

Consultative services in QM topics, optimization of QM Systems and Prozesses according to ISO13485, ISO9001, ISO14971, 21CFR Part 820, GMP etc. (main topics QC/QA, CAPA,NCRs, Complaints, Change Control, Training, Doc Control, Audit, Risk Management)

Ich biete

Management, Unternehmen, Strategie
  • Qualitätsmanagement (allg.)
  • Risikomanagement
  • Compliance management

Projekt‐ & Berufserfahrung

Senior QA Consultant
Constar GmbH, Basel-Land
4/2014 – 12/2014 (9 Monate)
Dienstleistungsbranche
Tätigkeitszeitraum

4/2014 – 12/2014

Tätigkeitsbeschreibung

Constar GmbH - Consultative services since April 2014
Consulting quality management topics, optimization of the QM Systems and processes according to ISO 13485, ISO 9001, DIN EN ISO 14971, 21CFR Part 820 and 21CFR Part 11, GMP
- Quality Control
- Quality Assurance
- Corrective and Preventive Action (CAPA)
- Nonconformity, Deviation, Complaint
- Risk Management, FMEA
- Change Control
- Documentation Control
- Training
- Auditing

Roles and responsibilities
• Management Office Northwest Switzerland
• Project Management of client projects
• Recruiting and on-boarding of QA consultants
• Coordinate training and qualification of junior QA consultants
• Supervising and monitoring performance of staff

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA, Change Management, Management (allg.), Prozessberatung, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management


EMEA CAPA Manager
DePuy Synthes GmbH (Johnson & Johnson Company), Zuchwil
6/2013 – 3/2014 (10 Monate)
Medical Device
Tätigkeitszeitraum

6/2013 – 3/2014

Tätigkeitsbeschreibung

• EMEA CAPA Manager of 13 Synthes manufacturing sites, leading one direct report
• EMEA CAPA process leader and representative in internal and external audits/inspections
• Lead EMEA CAPA review board (CRB)
• Review and approval of CAPAs as CRB member
• Member of EMEA Management Review
• Project Leader for the Global CAPA Legacy Review and Remediation Project
• Recruiting, on-boarding and supervising a team of 35 external CAPA consultants
• Lead a team of external CAPA consultants to support Europe-wide implementation of processes and systems to deliver consistent CAPAs compliant with company standards and Medical Device Regulations
• Coordinate daily huddles and ensure performance measurement of CAPA consultants
• Coordinate a team of CAPA trainers to deliver education and workshops to CAPA users
• Establish CAPA Train the Trainer concept and training effectiveness verification to ensure CAPA users are compliant with Synthes CAPA Content Standard (incl. Problem Statement, Risk assessment, Containment and Correction, Failure Investigation, Corrective and Preventive Action planning and implementation of actions including Effectiveness)
• Europe-wide roll-out of CAPA Review Boards (CRB)
• Europe-wide roll-out of CAPA KPIs/metrics including timeliness monitoring
• Deliver EMEA CAPA metrics to Management Review

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT), Change Management, Projektmanagement, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management


Corporate CAPA Manager
Institut Straumann AG, Basel
2/2010 – 5/2013 (3 Jahre, 4 Monate)
Medical Device
Tätigkeitszeitraum

2/2010 – 5/2013

Tätigkeitsbeschreibung

• Corporate CAPA Manager at Institute Straumann AG
• Ensure CAPA process execution, accountability and due diligence while interfacing closely with key members of management
• Drive improvements in product and process performance
• Corporate CAPA process representative in all internal and external audits/inspections
• Project Leader for design and development of web based Quality Management System (CAPA / NCR / Complaints / Audit observations management)
• Responsible for roll-out of Global Exception Management System and standardizing Straumann CAPA Management process across all sites
• Establishment of the Train-the-Trainer concept
• Responsible for developing and implementing measures to monitor the effectiveness of the CAPA process
• KPI reporting on a regular basis and supplying the status of CAPA/NCR metrics to Corporate Management Review process
• Lead MRB (Material Review Board) and CRB (CAPA Review Board) meetings

Special achievements
• Successful implementation of web-based QMS and elimination of CAPA backlog
• Successfully presented CAPA process during internal and external inspections
• Demonstrated leadership ability, excellent communication and training skills

Eingesetzte Qualifikationen

Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Rollout, Konzeption (IT), Technisches Qualitätsmanagement / QS / QA, Projektmanagement, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management


Functional Leader CAPA (Site CAPA Manager)
Abbott GmbH & Co. KG, Liestal
6/2006 – 1/2010 (3 Jahre, 8 Monate)
Pharma
Tätigkeitszeitraum

6/2006 – 1/2010

Tätigkeitsbeschreibung

• Site CAPA Manager at Abbott Liestal AG
• Responsible for the effectiveness and efficiency of the CAPA process
• Implementation and training of new CAPA policies and procedures
• Support manufacturing in addressing quality events related to product release including non-conformance, product disposition, root cause investigation, laboratory OOS, and corrective and preventative action
• Exert for Q-Metrics reporting
• Expert for Documentation Management System
• Lead Management Review Board and CAPA Review Board
• Establishment of supplier evaluation process and support Supplier Management activities

Special achievements
• Roll-out of several electronic systems at the site as a primary project lead (Documentation Management/Training/CAPA System)
• Successfully presented CAPA, Change Control and Management Review process as SME during FDA, SwissMedic and Abbott Corporate Audits
• Support process validation by participating in the development of validation protocols to assess manufacturing capability and reliability

Eingesetzte Qualifikationen

Qualitätsmanagement (allg.), Schulung / Coaching (allg.)


QA Compliance
Abbott GmbH & Co. KG, Liestal
7/2005 – 6/2006 (1 Jahr)
Pharma
Tätigkeitszeitraum

7/2005 – 6/2006

Tätigkeitsbeschreibung

• Process Owner for Stability Programs
• Responsible for performing trend analysis (Follow-up and On-going stability studies)
• Establishment of Stability Reports according to the GMP requirements

Eingesetzte Qualifikationen

Qualitätsmanagement (allg.)


Ausbildung

Chemistry with Marketing
(Dipl.Ing.(FH))
Jahr: 2005
Ort: Reutlingen

Qualifikationen

QUALIFIKATIONs:
Ongoing Study at SAQ-Qualicon "Qualitätsmanager" with diploma/certification in June 2015

On-the-job training
June 2011 Project Management II / Leadership, Basel
February 2011 Project Management I / Leadership, Basel
May 2009 Deviation Management and CAPA, Wien
October 2008 Methods for Effectiveness Checks, Mannheim
April 2008 Investigation Symposium, Prag
August 2007 OOS Results in the Analytical Lab, Investigation Methods & Exception Report
Writing Train-the-Trainer (TTT), Liestal
April 2007 European Investigation Symposium, Dublin
December 2006 Der GMP-Auditor, Intensiv-Seminar, Baden-Baden
April 2006 Investigation Symposium, Barcelona


August 2004 – February 2005
Diploma thesis at EADS Deutschland GmbH (R&D Daimler Chrysler)
Claude-Dornier-Straße
88090 Immenstaad, Germany

Scope
-Development of microencapsulated and Phase Change Materials
-Investigating new coolant concepts to improve the engine cooling effect


March 2003 – August 2004
Student trainee
Robert Bosch GmbH
Tübinger Strasse 123
72762 Reutlingen, Germany

Scope
-Improvement of press cut ceramic films
-Analysis of print pastes for screen and stencil printing process


January 2003 – July 2003
Second Internship
Robert Bosch GmbH
Tübinger Strasse 123
72762 Reutlingen, Germany

Scope
-Development of printing paste for master plate printing process of multilayered ceramics in automotive industry
-Gauge capability analysis of viscosity measuring instruments


July 2002 – December 2002
Study abroad
Swinburne University of Technology, Australia


September 2001 – February 2002
First Internship
Gambro Dialysatoren GmbH
Holger-Crafoord-Strasse 26
72373 Hechingen, Germany

Scope
- Manufacture and surface modification of membranes for hemodialysis
- Development of ATR-FTIR laboratory methods for polymer raw materials (Membrane & Device Research)
- Function tests, and ATR-FTIR, UV-VIS measurements for flat and hollow membrane production

Education
Date October 2000 – February 2005
Degree University studies in Chemistry and Marketing
Institution Reutlingen University
Alteburgstraße 150
72762 Reutlingen
Germany

Über mich

EMEA CAPA Manager at Synthes GmbH (June 2013 – March 2014)

Roles and Responsibilities:
- EMEA CAPA Manager of 13 Synthes manufacturing sites, leading one direct report
- EMEA CAPA process leader and repräsentative in infernal and external audits/inspections
- Lead EMEA CAPA review board (CRB)
- Review and approval of CAPAs as CRB member
- Member of EMEA Management Review
- Project Leader for the Global CAPA Legacy Review and Remediation Project
- Recruiting, on-boarding and supervising a team of 35 external CAPA consultants
- Lead a team of external CAPA consultants to support Europe- wide implementation of Prozesses and systems to deviier consistent CAPAs compliant with company standards and Medical Device Regulations
- Coordinate daily huddles and ensure performance measurement of CAPA consultants
- Coordinate a team of CAPA Trainers to deviier education and workshops to CAPA users
- Establish CAPA Train the Trainer concept and training effectiveness verification to ensure CAPA users are compliant with Synthes CAPA Content Standard (incl. Problem Statement, Risk assessment, Containment and Correction, Failure Investigation, Corrective and Präventive Action planning and implementation of actions including Effectiveness)
- Europe-wide roll-out of CAPA Review Boards (CRB) !Europe-wide roll-out of CAPA KPIs/metrics including timeliness monitoring
- Deviier EMEA CAPA metrics to Management Review


Process Owner (Corp. CAPA Manager) at Institut Straumann (February 2010 – Mai 2013)

Roles and Responsibilities:
- Ensure CAPA process Exekution, accountability and due diligence while interfacing closely with key members of management
- Drive improvements in product and process performance !Corporate CAPA process repräsentative in all infernal and external audits/inspections
- Project Leader for design and development of web based Quality Management System (CAPA / NCR / Complaints / Audit observations management)
- Responsible for roll-out of Global Exception Management System and standardizing Straumann CAPA Management process across all sites
- Establishment of the Train-the-Trainer concept
- Responsible for developing and implementier measures tomonitor the effectiveness of the CAPA process
- KPI reporting on a regulär basis and supplying the status of CAPA/NCR metrisch to Corporate Management Review process
- Lead MRB (Material Review Board) and CRB (CAPA Review Board) Meetings


Funktional Leader CAPA (Site CAPA Manager) at Abbott Liestal AG (June 2006 – January 2010

Roles and Responsibilities:
- Responsible for the effectiveness and Efficiency of the CAPA process
- Implementation and training of new CAPA policies and procedures
- Establishment of supplier evaluation process and support Supplik Management activities
- Support Process Valvation by participating in the development of validation protocols to assess manufacturing capability and reliability
- Support manufacturing in addressing quality events related to product release including non-conformance, product Disposition, root cause investigation, laboratory OOS, and corrective and preventative action
- Exert for Q-Metrics reporting
- Expert for Dokumentation Management System
- Lead Management Review Board and CAPA Review Board
- Roll-out of several electronic systems at the site as a primary project lead (Dokumentation Management/Training/CAPA System)



QA Compliance at Abbott Liestal AG (July 2005 – June 2006)

Roles and Responsibilities:
- Process Owner for Stability Programs
- Responsible for performing Trend analysis (Follow-up and On-going stability studies)
- Establishment of Stability Reports accordin

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Russisch (Fließend)
Reisebereitschaft
National
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
1116
Alter
40
Berufserfahrung
15 Jahre und 1 Monat (seit 07/2005)
Projektleitung
5 Jahre

Kontaktdaten

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

Jetzt Mitglied werden »