Hans-Herwig Bauer work email
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Hans-Herwig Bauer personal email
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.
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Vp, Technical Operations And QualityApiCanada -
Vp, Technical Operations & QualityApi Aug 2024 - PresentEdmonton, Alberta, CaReporting 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. -
Executive Director QualityOphtapharm Ag Aug 2023 - Aug 2024Hettlingen, Zurich, ChOversee 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 -
Director Of QualityAkorn, Inc Jan 2016 - Dec 2023Lake Forest, Il, UsOversee 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 -
Head Quality Unit SwitzerlandAcino Pharma Ag Jan 2014 - Dec 2015Zurich, Switzerland, ChHead 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. -
Head Quality ComplianceSandoz May 2013 - Dec 2013Basel, Basel-Stadt, ChHead 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. -
Quality Assurance ManagerLonza Aug 2005 - Apr 2013Basel, ChQA-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. -
Project-LeaderUniversity Marburg (Pharmacy, Institute For Phamaceutical Technology) Jan 2003 - Jul 2005Projectleader for synthesis and formulation of peptide and proteins and development of special drug delivery systems. Introducing of GMP-modules for GMP-manufacturing.
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Leader Of Special Lipide Diagnostic LaboratoryJ.W. Goethe University Hospital And Faculty Of Medicine (Dep. For Applied Biochemistry) Jan 2000 - Dec 2002Deputy 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
Hans-Herwig Bauer Education Details
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University Frankfurt (J.W. Goethe University Hospital And Faculty Of Medicine)Phd -
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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