Constantin Wieck
Hünstetten
Summary
What characterises me: (i) Visionary; (ii) Addressing and pursuing things; (iii) Developing colleagues & employees; (iv) Thinking and acting holistically
Where do I want to go: where I am part of a whole and can achieve goals together. Where I can shape things. Where I can improve or change.
My guiding principle: Standing still is a step backwards
Overview
23
23
years of professional experience
Work History
Head of Quality Assurance Operations
Biotest AG
01.2019 - Current
- Personnel management (45 employees) / Reorganisation / PQS (Deviations, CAPA, Change Control), SAP, Master Control
- FDA Inspection / Hosting of inspections by authorities and customers / Lead Auditor
- Risk management, Qualification, Validation, CMC
Head of Quality Assurance Systems
Biotest AG
05.2017 - 12.2018
- Personnel management (20 employees)
- Audit & inspection management / Supplier management / Document Management / Training Management
Head Quality Assurance Drug Product & QC
Biotest AG
05.2012 - 04.2017
- Personnel management (7 employees)
- Validation of Aseptic Processes (APS) and Qualification of equipment / QC method validation, CMC (production of clinical trial goods, product development)
QA Manager Fill and Finish
Biotest AG
07.2008 - 04.2012
- QA Manager for aseptic manufacturing, visual inspection and final packaging according to GMP Guideline Annex 1 and Guidance for Industry (FDA), Sterile Drug Products Produced by Aseptic Processing
- Qualification / Cleaning Validation / Process Validation / Environmental Monitoring
Teamlead GMP-Laboratory Microbiology
SGS Institut Fresenius
02.2007 - 06.2008
- Personnel management (up to 20 employees)
- Microbiological testing of sterile and non-sterile preparations according to Pharm Eur. and USP / customer audits and inspections by authorities
Projectmanager Microbiology
SGS Institut Fresenius
04.2002 - 01.2007
- Planning and implementation of microbiological projects and validation of microbiological laboratory methods
Education
Graduate Biologist -
Johannes Gutenberg-University
Mainz, Germany02-2002
Skills
- Leadership skills
- Commitment and proactive behaviour
- Ability to plan and organise
- Willingness to travel on business
- Project management skills
Languages
German
Bilingual or Proficient (C2)
Englisch
Advanced (C1)
Accomplishments
- Restructuring of QA concept, stabilisation of KPI
- Leading & Management of national and international inspections incl. FDA, ANVISA, Gulf States, Turkey, Russia, Iran, Regierungspräsidium Hessen (HLfGP), Paul-Ehrlich-Institut Langen
Timeline
Head of Quality Assurance Operations
Biotest AG
01.2019 - Current
Head of Quality Assurance Systems
Biotest AG
05.2017 - 12.2018
Head Quality Assurance Drug Product & QC
Biotest AG
05.2012 - 04.2017
QA Manager Fill and Finish
Biotest AG
07.2008 - 04.2012
Teamlead GMP-Laboratory Microbiology
SGS Institut Fresenius
02.2007 - 06.2008
Projectmanager Microbiology
SGS Institut Fresenius
04.2002 - 01.2007
Graduate Biologist -
Johannes Gutenberg-University
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