Hans-Herwig Bauer

Hans-Herwig Bauer Email and Phone Number

VP, Technical Operations and Quality @ API
Canada
Hans-Herwig Bauer's Location
Canada, Canada
Hans-Herwig Bauer's Contact Details

Hans-Herwig Bauer work email

Hans-Herwig Bauer personal email

n/a
About Hans-Herwig Bauer

With a proven record of success and extensive experience in the pharmaceutical quality assurance and regulatory sector, I stand out as a resourceful and results-driven leader. My expertise encompasses overseeing comprehensive quality operations, managing large teams, and handling complex projects with ease. I have demonstrated exceptional skill in developing and executing quality systems that adhere to stringent regulatory standards in multiple countries, including the US, EU, and Switzerland.My leadership extends to directing inspections, leading numerous quality improvement projects, and achieving significant advancements in production efficiency and product quality. As a visionary in quality management, I excel in the implementation of modern quality management systems and in enhancing data integrity. My contributions in GMP audits, 3rd party management, and analytical tasks have been pivotal in ensuring excellence in batch release processes.My approach combines strategic oversight with a hands-on understanding of the technical intricacies, enabling me to drive operations that meet and exceed industry standards. I am recognized for my ability to navigate the complexities of the regulatory environment, ensuring compliance and operational excellence across the board.

Hans-Herwig Bauer's Current Company Details
API

Api

View
VP, Technical Operations and Quality
Canada
Website:
appliedpharma.ca
Employees:
112
Hans-Herwig Bauer Work Experience Details
  • Api
    Vp, Technical Operations And Quality
    Api
    Canada
  • Api
    Vp, Technical Operations & Quality
    Api Aug 2024 - Present
    Edmonton, Alberta, Ca
    Reporting to the CEO, responsible for building up a new commercial manufacturing organization including Quality regarding all important areas to assist the Canadian Critical Drug Initiative and lead these department in the future for manufacturing.That include: 1) The lead for building, qualification and registration activities of the new Critical Medicines Production center (CMPC).This will be a new 83,000+ square-foot manufacturing facility with aseptic sterile filling and terminal sterilization for sterile products especially injectables with automated filling line and modern equipment. In addtion Formulation area, Warehouse QC and Mikrobiolab.2) To build up in a current center Biotechnology Business Development Centre (BBDC) an API-production plant with QC-lab and Warehouse.
  • Ophtapharm Ag
    Executive Director Quality
    Ophtapharm Ag Aug 2023 - Aug 2024
    Hettlingen, Zurich, Ch
    Oversee all quality assurance and quality control operations for manufacturing of sterile ophthalmic drug products and transfers with a focus on the US market. Optimise global quality standards and drive improvement initiatives. Manage all QA and QC activities, including chemical and physical testing, microbiology lab operations, environmental monitoring, qualification and validation processes, documentation, training, data integrity, batch release procedures, and QA-related tasks. Handle inspections from regulatory bodies such as FDA, Swiss Medic, and EU-GMP.● Served as the Deputy of the Site Manager, and acted as the Deputy of the Site's Functional Vice President.● Led a team of 110 employees, including QA and QC managers, with responsibilities for team leadership and management.● Oversee projects and product transfer activities
  • Akorn, Inc
    Director Of Quality
    Akorn, Inc Jan 2016 - Dec 2023
    Lake Forest, Il, Us
    Oversee all quality assurance and quality control operations for manufacturing of sterile ophthalmic drug products and transfers with a focus on the US market. Optimise global quality standards and drive improvement initiatives. Manage all QA and QC activities, including chemical and physical testing, microbiology lab operations, environmental monitoring, qualification and validation processes, documentation, training, data integrity, batch release procedures, and QA-related tasks. Handle inspections from regulatory bodies such as FDA, Swiss Medic, and EU-GMP.● Served as the Deputy of the Site Manager, and acted as the Deputy of the Site's Functional Vice President.● Led a team of 110 employees, including QA and QC managers, with responsibilities for team leadership and management.● Oversee projects and product transfer activities
  • Acino Pharma Ag
    Head Quality Unit Switzerland
    Acino Pharma Ag Jan 2014 - Dec 2015
    Zurich, Switzerland, Ch
    Head of Acino Quality unit Switzerland. In Addition Global Head of QU Acino-Supply responsible also for outsourced acitivities. Reporting line to the Head of group quality, member of the executive board. Responsible for all QA and QC-acitivities in Switizerland. Responsible for three manufacturing sites in Aesch (solid pharmaceutical products), Liesberg (solid pharmaceutical products) , Aesch (packaging line). 4 direct reports, about 90 indirect reports (25 QA and 65 QC) including 4 Qualified persons (FvP) for different sites and business sectors in Switzerland. Implementation and Review and approval of Quality processes and projects.
  • Sandoz
    Head Quality Compliance
    Sandoz May 2013 - Dec 2013
    Basel, Basel-Stadt, Ch
    Head of Quality compliance at SANDOZ, EBEWE- oncology injectables : leading four QA-groups: QA-goup for QC, Auditor group and 3rd Party management, Group for validation and qualification, and group for quality compliants and connection to authorities. Responsibility for the budget for the quality compliance department. Professional contact for local and global tasks and projects in the quality compliance area. Implentation, review and approval of quality projects and processes.
  • Lonza
    Quality Assurance Manager
    Lonza Aug 2005 - Apr 2013
    Basel, Ch
    QA-manager in the area of custom manufacturing with special focus for Peptide and Oligonucleotide projects. QA-operation tasks with strong focus on customer and regulatory requirements. Batch release, deviation and change management, qualification risk analysis, process validation, annual product reviews,cleaning. Lead Auditor for supplier and customer audits.
  • University Marburg (Pharmacy, Institute For Phamaceutical Technology)
    Project-Leader
    University Marburg (Pharmacy, Institute For Phamaceutical Technology) Jan 2003 - Jul 2005
    Projectleader for synthesis and formulation of peptide and proteins and development of special drug delivery systems. Introducing of GMP-modules for GMP-manufacturing.
  • J.W. Goethe University Hospital And Faculty Of Medicine (Dep. For Applied Biochemistry)
    Leader Of Special Lipide Diagnostic Laboratory
    J.W. Goethe University Hospital And Faculty Of Medicine (Dep. For Applied Biochemistry) Jan 2000 - Dec 2002
    Deputy of the Dep. for applied Biochemistry. Head of lipid laboratory for special lipid analytic and diagnostic. Development of biochemical analytical methods. Education of students of Medicine, Biochemistry and Chemistry.

Hans-Herwig Bauer Skills

Gmp Validation Capa Pharmaceutical Industry Trackwise Sop Quality Auditing Quality Management Risk Management Chemistry Change Control Biotechnologie Biopharmaceuticals Technology Transfer Lifesciences Sap 21 Cfr Part 11 Biochemistry Biotechnology Lims Dms Medical Diagnostics Clinical Trials Biowissenschaften Pharmaindustrie Operational Excellence Technologietransfer Biopharmazeutika Chemie Klinische Studien

Hans-Herwig Bauer Education Details

  • University Frankfurt (J.W. Goethe University Hospital And Faculty Of Medicine)
    University Frankfurt (J.W. Goethe University Hospital And Faculty Of Medicine)
    Phd
  • University Frankfurt (Chemistry)
    University Frankfurt (Chemistry)
    Chemistry

Frequently Asked Questions about Hans-Herwig Bauer

What company does Hans-Herwig Bauer work for?

Hans-Herwig Bauer works for Api

What is Hans-Herwig Bauer's role at the current company?

Hans-Herwig Bauer's current role is VP, Technical Operations and Quality.

What is Hans-Herwig Bauer's email address?

Hans-Herwig Bauer's email address is ha****@****orn.com

What schools did Hans-Herwig Bauer attend?

Hans-Herwig Bauer attended University Frankfurt (J.w. Goethe University Hospital And Faculty Of Medicine), University Frankfurt (Chemistry).

What skills is Hans-Herwig Bauer known for?

Hans-Herwig Bauer has skills like Gmp, Validation, Capa, Pharmaceutical Industry, Trackwise, Sop, Quality Auditing, Quality Management, Risk Management, Chemistry, Change Control, Biotechnologie.

Who are Hans-Herwig Bauer's colleagues?

Hans-Herwig Bauer's colleagues are Marcelo Osvaldo Biancotti, Fernanda Talarico, Phd, Rungu Mondlane, Marina Bolshakova, Siddhartha Biswas, Marina Barbu, Daniel Schieman.

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