Dr. Oleg Lapochkin
Angestellt, Qualified Person / Head of Quality Control, Catalent Germany Eberbach GmbH (Eberbach, Germany)
Eberbach, Deutschland
Werdegang
Berufserfahrung von Oleg Lapochkin
Bis heute 7 Jahre und 6 Monate, seit Jan. 2017
Qualified Person / Head of Quality Control
Catalent Germany Eberbach GmbH (Eberbach, Germany)
- classical duties of Head of QC (EU GMP, Clause 2.6) - leading the employees - developing a QA program (Deviation Management Excellence)
Quality Control, QMS, Qualified Person Assistent
9 Monate, Juli 2012 - März 2013
Qualified Person Assistant
Klocke Verpackungs-Service GmbH (Weingarten, Germany)
- batch records review (pre-release), - CoA, CoC review - project leading (process re-validation, equipment qualification, process improvement) - preparing and writing SOPs, Protocols - training employees - recurrent organization of self-inspections and Audits
2 Jahre und 1 Monat, Apr. 2010 - Apr. 2012
QC/QA
AgenoLAB GmbH & Co. KG (Stuttgart, Germany)
– planning and carrying out of microbiological and molecular biological analyses - developing a QA program (change control, corrective and preventive actions etc.) as well as GDP (Good Documentation Practice) - administration of the QA program - preparing and writing SOPs, VMP (Validation Master Plan) - training employees - recurrent organization of self-inspections and Audits - preparation of a corrective action plan for observations - formulation of a quality release in the field of documentations
1 Jahr und 7 Monate, Aug. 2008 - Feb. 2010
Project Manager / Service Engineer
Lumex-Centrum Ltd. (Moscow, Russia)
– starting-up and adjustment of equipment (fluorometers, HPLC and capillary electrophoresis systems, IR and near IR-spectrometers, AAS etc.) as well as their technical support and maintenance – customer service and consulting – marketing analysis – organization of seminars and symposiums for production advancements
3 Jahre, Sep. 2005 - Aug. 2008
Head of Laboratory / Researcher
Pyatigorsk State Pharmaceutical Academy (Russland)
– work planning and coordination in laboratory – planning and coordination of validation of analytical methods for pharmaceutical analysis – carrying out of quality control substances, intermediate and finished products under Pharmacopoeias – participation in scientific research studies on various topics – writing scientific articles and reports – participation in regional, interregional, and international conferences
Ausbildung von Oleg Lapochkin
3 Jahre, Sep. 2005 - Aug. 2008
Pharmacy: Postgraduate study
Pyatigorsk State Pharmaceutical Academy
Thesis “Synthesis and Research Vanadyl Complex Compounds with Amino Acids: Glycine, α-Alanine, β-Alanine“ has been performed and successfully defended. New vanadyl complex compounds have been investigated by different physically-chemical and pharmacological methods.
4 Jahre und 11 Monate, Sep. 2000 - Juli 2005
Pharmacy
Pyatigorsk State Pharmaceutical Academy
The Diploma Qualification “Syntheses and Research of Vanadyl Complex Compound with Glycine”. Awarded the State Fellowship. Graduated with honors.
Sprachen
Russisch
Muttersprache
Englisch
Gut
Deutsch
Gut