Andreas Kalanzis
Selbstständig, Geschäftsführer, Kalanzis Consulting
Ellern, Deutschland
Werdegang
Berufserfahrung von Andreas Kalanzis
Independent Consultant for auditing and consultancy for GxP-themes according EU GMP-Leitfaden Annex 11, US Code of Federal Regulations, Title 21 Part 11. PIC/S PI 011-3 Good Practices for Computerised Systems In Regulated Gxp Environments ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems Current Annex 1 Risk Assessment and CCS implementation Independent Consultant as negotiator and Auditor for work council agreements for CS (BDSG, BetrVG)
1 Jahr und 2 Monate, Dez. 2022 - Jan. 2024
External QA support for GMP and CSV for a German manufacturer of Lab equipment
Not for Public
Building up the QMS of the manufacturer as well as creating Validation Plan and validate with company empoyees the first GMP compliant Lab Equipment. Ongoing support for GMP and CSV topics.
7 Monate, Juni 2023 - Dez. 2023
Interim Site Quality Head at a German man. of a Biological Product for EU and US
Not for Public
Quality Strategy, Quality Systems, Quality Compliance EU and US, Inspections, Peoples Q-Mentality, Budget Q-Organisation, Communication Internal-External, Training Annex 1 in English and German, RA according to Annex 1 vs. older Versions implemented on site. CCS according Annex 1. SOPs for sterile Biologics especially for QC (APS and VI), Facility-specific germ Database.
Closing Gaps at the Quality Management System of STADA/Mobilat GmbH and train employees in GMP and CSV for the upcoming authority inspection.
Closing Gaps at the Quality Management System of STADA/Mobilat GmbH and train employees in GMP and CSV for the upcoming authority inspection.
Assessing the potential Risk of medicinal products containing chemically Synthesized APIs for N-Nitrosamine Impurities of all Novartis and affiliates portfolio.
3 Monate, Okt. 2019 - Dez. 2019
Strategic Business Consultant
Glenmark
API importation from India and Korea over US as well as further processing till EU QP release of the finished product. Distribution in the EU. Strategy and project plan of the potential Side movement.
1 Jahr und 2 Monate, Aug. 2018 - Sep. 2019
Managing as Commercial Quality the Central Warehouse of Biogen GmbH
Biogen International GmbH
Responsible for all processes around the Central Warehouse, the shipping lanes worldwide, shipping qualifications, affiliates relations, external partner relations such 3PL, wholesalers, distributors. Conducting GDP audits worldwide and following up Logistic and Security issues. Also responsible to and successfully improve and increase robustness for all Computerized Systems related to the logistic and commercial part such interfaces with partners, Biogen CSs, Master Data.
1 Jahr und 2 Monate, Juni 2017 - Juli 2018
Interim Head of International Product Complaints Department
Biogen GmbH1 Jahr und 2 Monate, Nov. 2014 - Dez. 2015
QA Manager
Sharp
1 Jahr und 9 Monate, Apr. 2014 - Dez. 2015
Leitender prozessingenieur
Reppos Shipyard
1 Jahr und 1 Monat, Nov. 2011 - Nov. 2012
Qualitätssicherungs Manager
DeLaval
6 Monate, Mai 2011 - Okt. 2011
Leitender Projekt Manager
Oniro by Epsilon Kosmetik
9 Jahre und 2 Monate, März 2002 - Apr. 2011
Corporate Computer Validation Officer, Corporate Lead Auditor
Boehringer IngelheimPerforming GMP and CSV&C corporate audits as a lead auditor. Performing Supplier Audits for Supplier Qualification. Responsible QA Person to release Corporate Computerized Systems in terms of Validation and Part/annex 11 Compliance. Implementation of the Corporate Policy on Computer Systems Validation and Compliance (CSV&C). Coordination of international Teams to develop and design Corporate Computerized Systems. Interpretation of international Requirements, Guidance’s, Guidelines to CSV&C.
1 Jahr und 10 Monate, Juni 2000 - März 2002
Auditor
Boehringer Ingelheim KG
Supplier Qualification and Self Inspections at Pharma and Chemicals area.
3 Jahre und 6 Monate, Jan. 1997 - Juni 2000
Head of the Final Release
Boehringer Ingelheim KG
Bach Record Review, Errors and Deviations Handling, Final Release. Develop, validate and implement a Database for handling of Errors, Deviations, and Changes at two German sites with more then 500 users. Part Project Leader at the SAP Implementation.
Sprachen
Englisch
Fließend
Griechisch
Muttersprache
Spanisch
Gut
Deutsch
Muttersprache