Summary
Overview
Work History
Education
Skills
Training
Websites
Interests
References
Timeline
Generic

Patricia Luchies

Quality
Münsingen

Summary

Experienced Quality Manager with strong people management skills, using a coaching style to develop teams. Skilled in supplier auditing, complaint management, and quality management, with a focus on improvement, communication, and operational effectiveness in diverse environments.

Overview

34
34
years of professional experience
3
3
Languages

Work History

Advanced Quality Consultant

Capgemini Engineering
01.2023 - 06.2025
  • Customer: CQV QDoc Team Lead/QA Manager consultants at CMDO client.
  • First point of contact between client and team responsibility for P&ID/Slope checks on site, TCCC verification (remote team) and QA review of CQ document. Coaching and high level coordination of the team.
  • Customer: (interim) Supervisor QA OPS Bioconjugates at CMDO client.
  • Lead/coach a young QA PM team to ENG run, successful SwissMedic Inspection, first GMP batches production and release. Part of QALT.
  • Customer: Initiating a taskforce at a customer (CMDO - Life Sciences) site to reduce a specific type of Deviations within QC Biologics as well as supporting Equipment deviations.
  • Internal: Training & Leading an internal project to improve and internal processes. Assisting pre-sales. Mentor

Project Manager QC Method Transfer EN

Fresenius Kabi - EN, Emmer-Compascuum
01.2022 - 11.2023
  • Responsible for the continuation of the transfer & implementation of all EN analytical methods in collaboration with the Bad Homburg production location.
  • Building and leading a team of 4 FTE Lab specialists.
  • Supporting lab extension project.

Head of QC&Labs (interim)

Fresenius Kabi - EN, Emmer-Compascuum
01.2021 - 01.2022
  • Interim QC manager to cover maternity leave at the new Fresenius Kabi production location for Enteral Nutrition. The QC department includes the laboratory segments Raw Material Control, Instrumental Analysis, Final Control&Packaging and Micro Control.
  • Responsible for the continuation of the transfer & implementation of analytical methods in collaboration with the Bad Homburg production location as well as moving to an operational phase during the start-up of the production location.
  • Identification and support to several RCA related to start-up deviations in production.
  • Building the QC organization (expanded from 9 to ca. 15 FTE).
  • Member of Site Leadership Team

Quality Manager

Melspring (Olmix)
01.2019 - 08.2020


  • Quality Manager for Melspring International activities and the production locations in Rogat(NL) and Nordenham(D), as well as sales locations in Velp(NL) and Perpignan (F). Included as well are several contractor activities (storage, repacking, production). Main sales areas are (but are not limited to) Europe and Asia. Member of Leadership Team
  • Products include trade of GMP+ products (Animal Care), mineral organic fertilizers (Pant Care), water care products and Ferro Sulphate.
  • Responsibilities included but are not limited to:
  • Registration support of regulatory department. MSDS coordination, SPOC for all quality related matters. Review and approval of specifications. GMP responsible. ISO-9001 responsible. Auditor intern and extern. Quality responsible for external manufacturing and suppliers. Customer complaint coordination and support. Work process development and alignment. Tracking and trend analyses. Supplier qualification and evaluation.
  • Change management quality owner.

Donation Leader

IAMS
08.2009 - 12.2018
  • Coordination of the donation of available product to welfare(voluntary, not part of job descripotions).

QA Specialist

IAMS
06.2018 - 12.2018
  • Investigation and report on a review of finished product characteristics performance against formulations and regulatory limits. This included the identification of risk formulations, recommended new specification setting and an updated raw material testing strategy proposal. Developed a tracking and updating method to enable proactively trending of every individual formulation.
  • Review & update of the Raw Material Risk Assessment (GIRA) for HACCP.

QA Contractors and Consumer Complaints Leader

IAMS
04.2015 - 06.2018
  • Spectrum Brands Pet Companion Consumer Complaint leader (Regional Ownership).
  • Performing trend analyses, reports, complaint investigation, consumer care line training and guidance as well as SPOC for all business representatives.
  • Performing QA QAKE audits both internally and externally (raw & pack material suppliers and external manufacturing).
  • QA responsible for contractors (external manufacturers, manipulation & storage) including setting up SLA, specification review & approval and follow up on deviations.
  • Auditee relevant subjects PFIAA, IFS, nVWA audits.

QA Systems Leader New Technologies & Compliance

IAMS
02.2011 - 03.2015
  • Coordination and SPOC of Pet Care Consumer Complaint investigations (All regions except LA & NA).
  • Member of Global P&G Health & Wellbeing Consumer Comment Steering Team.
  • Member (and leading the EU side) of cross-level and multi-functional global P&G Pet Care Raw Material Specification Renewal team, updating all specification to current standards.
  • Coordinator of the implementation of new materials and standards locally.
  • Conducting both internal and supplier QA audits (P&G 19KE QAKE system).
  • Support in developing of Human Sensory technology and implementing locally.
  • Auditee relevant subjects PFIAA, ISO22000:2005, nVWA, 19KE QAKE P&G audits.

Logistics Material Supply Management

IAMS
04.2007 - 01.2011
  • SPOC between suppliers and plant
  • Logistical issues and invoicing follow up.
  • Development of SLEA agreements with all suppliers(internationally).
  • Optimization of work processes (scorecards, quality defects, supply chain).
  • Member of global cross-level and multi-functional global MSM team.
  • Optimization projects by e.g. using VSM together with purchasing, QA and planning ü Set up & maintenance coordination of SA/PO’s in SAP.
  • P&G Supplier Portal set up, maintenance and training.
  • Development of MSM Supply Chain Scorecard (SCS), presented at the MSM EMEA convention (12/2009, Mechelen, Belgium) and the MSM US convention (02/2010, Cincinnati, OH USA).
  • Present Off-Quality management handling process at the MSM EMEA convention (12/2009, Mechelen, Belgium).
  • Co-trainer at SLEA training at MSM EMEA/EAST convention (12/2010, Cairo, Egypt).
  • Created an Access off-quality database enabling tracking of material quality deviations, corrective actions and follow up.
  • Leading weekly meetings to improve supplier and material performance with purchasing, planning and QA.

QA Assistant (dayshift)

IAMS
10.2005 - 03.2007
  • Monthly reports (e.g. First Time Right, PQM).
  • Complaint investigations.
  • Evaluate and assigning corrective actions related to off quality product.
  • Coordinator collaborative testing and QA training.
  • Conducting internal P&G QAKE 19KE audits.
  • Manual Master administrator.
  • Development of QA procedures and work instructions.
  • External laboratory and supplier SPOC.
  • New equipment validation.
  • Backup QA Manager.
  • Auditee relevant subjects AIB audit.

QA Laboratory Technician (3,4 & shift model)

IAMS
12.1998 - 09.2005
  • Plant start-up support.
  • Incoming material testing.
  • Calibration & maintenance.
  • Cleaning and in-production checks
  • Off quality product blocks, investigation and disposition.

(voluntary) Autosport reporter

Autosport.nu
01.2010 - 01.2012
  • On location (press room), writing live (online) race reports.

QA Temporary Physical Laboratory Technician

DSM
09.1998 - 12.1998
  • Extruding of granules into required test shapes
  • Physical testing (e.g. resistance, break point, color).

QA Chemical Lab Technician, 3 shifts

Fresenius Hemo Care
09.1996 - 09.1998
  • Various chemical tests, including HPLC, AAS, Spectrometry, material identification testing
  • Validation FTIR

Intern at Microbiological Laboratory

WLN
01.1996 - 08.1996
  • Testing & identification
  • Reference standard culture maintenance
  • Test plate preparation.

Intern at Chemical Laboratory

Tauw Milieu
09.1995 - 01.1996
  • Chemical Testing
  • Storeroom management
  • Training of basic test methods

Part Time general employee

Rosery Raadschelders
05.1991 - 09.1996
  • All general activities
  • Training &coaching of new employees

Education

Leadership and Disruption

Fundação Instituto De Administração (Coursera)
01.2024

Lean Six Sigma Green Belt

ISBW
01.2023

Process management & lean

ICM
01.2022

Higher Management

ICM
01.2018

Advanced Microbiology

Hall Institute
01.2004

Bio-Analytical-Chemical

Drenthe College
01.1990

MAVO-D

De Horizon
01.1990

Skills

    Quality management

    Supplier management

    People management

    Project management

    Change management

    Complaint management

    Analytical

    QA/QC

    Auditing

    Quality standards

    Project management

    Continuous improvement

    Auditing

    Project management

    Risk management

    Collaboration skills

Training

Quality

  • 2024, Non conformity management, Udemy
  • 2024, FMEA, Udemy
  • 2022, Internal auditing (ISO 9001/FSCC22000), Fresenius
  • 2018, Basic HACCP, LRQA
  • 2018, ISO 9001:2015, Lead Auditor, LRQA (certificate 117404)
  • 2016, Pest Prevention, Lamon
  • 2016, IFS Food Standard, KTBA
  • 2016, Preventive controls for Animal Feed, FSPCA
  • 2015, HACCP Team Basic, KTBA
  • 2014, ISO 22000:2005, DNV
  • 2013, QAKE 19KE-auditor (certified), P&G
  • 2006, Basic QAKE 19KE 2 day, P&G
  • 2004, LECO Tru-Spec, LECO
  • 2000, LECO FP-528, LECO
  • 2000, FOSS NIR Beginner, FOSS
  • 2000, FOSS NIR Advanced, FOSS
  • 1996, GMP, Fresenius Hemo Care

Personal Development

  • 2021, Situational Leadership, Fresenius
  • 2011, Improving your personal Leadership, P&G2010, High Performance Organization (HPO), P&G
  • 2010, 7 Habits of Highly Effective People, P&G
  • 2010, IWS AM Step 1.5(Autonomous maintenance), P&G
  • 2009, Workshop Project Management, P&G
  • 2008, People & Communication Skills, P&G
  • 2008, Coaching for Everybody, P&G

Logistics

  • 2010, MSM College (Cincinnati, USA), P&G
  • 2010, Integrated Supply Network Loss Analyses, P&G/Cranfield University
  • 2009, MSM College (Mechelen, Belgium), P&G
  • 2007, MSM EU College (Newcastle, UK), P&G

Other

  • 2013, Basic Equine Nutrition, Royal (Dick) School of Veterinary Study, University of Edinburgh
  • 2011, Basic Validation, P&G2008, Basic Statistics, P&G
  • 2008, AIM Datalog System & Analyse, Roteg
  • 2006, Extruder Training/BPV, Wenger
  • 2000, VVA-1, IVM
  • 2000, Workshop Quality Analyst, P&G

Interests

Travelling, nature, reading, autosport, animals, cycling, wintersports, gaming, music

References

Available on request.

Timeline

Advanced Quality Consultant

Capgemini Engineering
01.2023 - 06.2025

Project Manager QC Method Transfer EN

Fresenius Kabi - EN, Emmer-Compascuum
01.2022 - 11.2023

Head of QC&Labs (interim)

Fresenius Kabi - EN, Emmer-Compascuum
01.2021 - 01.2022

Quality Manager

Melspring (Olmix)
01.2019 - 08.2020

QA Specialist

IAMS
06.2018 - 12.2018

QA Contractors and Consumer Complaints Leader

IAMS
04.2015 - 06.2018

QA Systems Leader New Technologies & Compliance

IAMS
02.2011 - 03.2015

(voluntary) Autosport reporter

Autosport.nu
01.2010 - 01.2012

Donation Leader

IAMS
08.2009 - 12.2018

Logistics Material Supply Management

IAMS
04.2007 - 01.2011

QA Assistant (dayshift)

IAMS
10.2005 - 03.2007

QA Laboratory Technician (3,4 & shift model)

IAMS
12.1998 - 09.2005

QA Temporary Physical Laboratory Technician

DSM
09.1998 - 12.1998

QA Chemical Lab Technician, 3 shifts

Fresenius Hemo Care
09.1996 - 09.1998

Intern at Microbiological Laboratory

WLN
01.1996 - 08.1996

Intern at Chemical Laboratory

Tauw Milieu
09.1995 - 01.1996

Part Time general employee

Rosery Raadschelders
05.1991 - 09.1996

Lean Six Sigma Green Belt

ISBW

Process management & lean

ICM

Advanced Microbiology

Hall Institute

Bio-Analytical-Chemical

Drenthe College

Leadership and Disruption

Fundação Instituto De Administração (Coursera)

Higher Management

ICM

MAVO-D

De Horizon
Patricia LuchiesQuality