Agata Ochocinska
Head of Quality & Regulatory Europe, Actylis at Actylis- Claim this Profile
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Bio
Experience
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Actylis
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United States
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Chemical Raw Materials Manufacturing
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100 - 200 Employee
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Head of Quality & Regulatory Europe, Actylis
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Sep 2022 - Present
Heading an international team of Quality and Regulatory experts supporting Actylis LifeScience organisation in API/ EXP, Cosmetics, Nutrition, PI and SC business units.
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Senior Manager Quality
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May 2022 - Sep 2022
Quality Team manager dealing with QA QC aspects for chemicals destined for speciality chemicals businesses as well as pharma, nutrition and cosmetic areas.
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Sigma-Aldrich
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Biotechnology Research
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700 & Above Employee
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Quality Manager Sigma Aldrich France
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Oct 2018 - May 2022
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Siegfried
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Engineer
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Oct 2015 - Sep 2018
- Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - New Process Validation/ complementary validation - raw materials qualification - new Process implementation : portfolio follow up/ Operational Risk Analysis/ set-up optimisation - Project Management (new process evaluation/ feasibility studies/ quotations/ contribution to final offer proposal) - SAP Key User - Managing a portfolio of products (customer communication, process implementation and validation, routine manuifacturing follow up, etc.) - Communication with customers/ Suppliers both international - Direct management Show less
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BASF Pharma Saint-Vulbas
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Saint-Vulbas, France
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Quality Assurance Engineer
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Dec 2014 - Oct 2015
- Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - Product Batch Validation process follow-up - Managing a portfolio of products - Communication with customers/ Suppliers - Quality Assurance in API's manufacturing (GMP/ ICH Q7) - Change Control/ Deviation/ OOS - Product Batch Validation process follow-up - Managing a portfolio of products - Communication with customers/ Suppliers
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BASF
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Germany
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Chemical Manufacturing
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700 & Above Employee
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Site Quality Manager Intern
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Feb 2014 - Aug 2014
- ISO/TS 16949 and its requirements; analys- Quality Management System analysis; process optimisation; process troubleshooting and follow-up ; - internal audits - process audits (5M); -Risk Assessment Tools (FMEA, FTA) and fault analysis tools (ex. 8D, 5M) - initiating the Site Risk Landscape (in preparation for ISO 9001 v 2015) - update of process FMEA and related documentation (Monitoring Plans) - ISO 31000 (and 31004); ISO 19011; ISO 14001 - ISO/TS 16949 and its requirements; analys- Quality Management System analysis; process optimisation; process troubleshooting and follow-up ; - internal audits - process audits (5M); -Risk Assessment Tools (FMEA, FTA) and fault analysis tools (ex. 8D, 5M) - initiating the Site Risk Landscape (in preparation for ISO 9001 v 2015) - update of process FMEA and related documentation (Monitoring Plans) - ISO 31000 (and 31004); ISO 19011; ISO 14001
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Consultant
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Sep 2011 - Oct 2011
Consultant, organic synthetic chemistry;
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Consultant
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Sep 2011 - Oct 2011
I solved a synthetic problem blocking production of multiple key molecules.
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Lund University
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Sweden
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Higher Education
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700 & Above Employee
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Post-Doc
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Oct 2009 - Apr 2011
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University of Reading
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United Kingdom
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Higher Education
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700 & Above Employee
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PhD
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2005 - 2010
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Education
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Université de Technologie de Compiègne, Compiègne
Master's degree, Qualité et Performance dans les organisations/Quality and Performance -
The University of Reading
Ph.D., Organic Chemistry -
Uniwersytet im. Adama Mickiewicza w Poznaniu
Masters, Chemistry