Microsoft Office
Pavel Jeřábek
Quality Assurance Professional
Prague
Summary
Experienced, innovative and strongly motivated quality assurance and regulatory affairs professional with proven tracked record of 10+ years in the medical cannabis industry.
Overview
16
16
years of professional experience
12
12
years of post-secondary education
4
4
Languages
Work History
Head of Quality Assurance
SensiQure
Prague
02.2023 - Current
- Fully responsible for the creation and implementation of the whole quality management system
- Responsible for validation and qualification management including computerized systems
- Successfully passed the inspection from the national authority and received EU GMP certification to produce cannabis for medicinal use
Co-founder, Director of Reg. & Scientific Affairs
Herbology Ventures
Prague
02.2023 - Current
- Director and co-founder in the advisory company
- Providing business, regulatory & legal services for cannabis commerce in Europe through smarter cannabis strategies
Senior Quality Assurance Consultant
TRUSTT
Warsaw
01.2023 - Current
- Responsible for TRUSTT GACP module regulatory compliance
- Responsible for auditing and compliance strategies
- Responsible for onboarding procedure of new clients through GACP
- Performing technical presentations of product features
Senior Quality Assurance Specialist
Tilray
Cantanhede
08.2018 - 02.2022
- Worked for Tilray EU Quality Assurance unit
- Was responsible for the compliance with EU Quality Management System requirements including controlled documentation creation and management
- Was leading product quality complaints investigation, change control and corrective and preventive action management, deviation management and risk assessment procedures
- Was responsible for 'New Market Opportunities' projects, product registration and requirements
- Was managing scientific advise procedures with competent authorities
- Was leading registration procedures of products in UK, Ireland, Croatia, Poland, Switzerland, Greece and North Macedonia
- Was responsible for KPI management and reporting
International Cannabis Auditor
International Cannabis and Cannabinoids Institute (ICCI)
Prague
01.2018 - 07.2018
- Drafted audit plans, agendas and protocols
- Performed audits as lead auditor
- Provided regulatory advice services for EU clients working in the cannabis industry
- Contributed to the generation of proprietary auditing standards for cannabis GACP and GMP
International CRO Manager
PharmInvent
Prague
09.2017 - 07.2018
- Was responsible for pre-clinical studies (cannabis) management and coordination
Regulatory Affairs Specialist
PharmInvent
Prague
01.2017 - 07.2018
- Performed medical writing of clinical and non-clinical overviews and clinical trial protocol and dossier
- Managed clinical trial application and approval process
Quality Assurance Specialist, Auditor
PharmInvent
Prague
05.2017 - 08.2017
- Performed internal and external audits
- Drafted quality documents (SOP, WI, QTF)
Medical Cannabis Specialist
State Institute for Drug Control (SÚKL)
Prague
11.2016 - 04.2017
- State Agency for Medical Cannabis
- I was responsible to manage tasks of the public tender for cultivation and manufacturing of cannabis for medical use including contracts for distribution
- I communicated with healthcare professionals and developed internal processes and documentation
Inspector In Quality Assurance
State Institute for Drug Control (SÚKL)
Prague
05.2014 - 10.2016
- I was GMP, GDP, GACP (Medical Cannabis) inspector
- I was performing inspections of domestic medical cannabis production according to European and Czech regulations
Co-owner, Pharmacist
JEPHARMA
Litomerice
01.2007 - 04.2014
- Family owned business
- Acquired knowledge about pharmacy operations
Education
Master of Science - Pharmacy
Faculty of Pharmacy, Charles University
Prague 10.2002 - 10.2006
Ph.D. - Pharmacology And Toxicology
3rd Faculty of Medicine, Charles University
Prague 10.2011 - 10.2019
Skills
Quality assurance and quality management
Regulatory affairs and medical writing
Organisation and project management
Communication
Affiliations
- Member of ASTM International
- Member of Consorzio Italbiotec
Software
TrackWise
Acumatica
Orgnes
Scientific Publications
- 2017 - Ghrelin receptor antagonism of morphine-induced conditioned place preference and behavioral
and accumbens dopaminergic sensitization in rats; Jerabek P, Havlickova, Puskina N, Charalambous C,
Lapka M, Kacer P, Sustkova-Fiserova M (Neurochemistry International; IF = 3,46) - 2017 - Alterations in rat accumbens endocannabinoid and GABA content during fentanyl treatment: The
role of ghrelin; Sustkova-Fiserova M, Charalambous C, Havlickova T, Lapka M, Jerabek P, Puskina N, Syslova
K (Int. Journ. of Molecular Sciences; IF = 3,23) - 2015 - Ghrelin and endocannabinoids participation in morphine-induced effects in the rat nucleus
accumbens; Sustkova-Fiserova M, Jerabek P, Havlickova T, Syslova K, Kacer P (Psychopharmacology; IF =
3,88) - 2015 - Reward related neurotransmitter changes in a model of depression: An in vivo microdialysis study;
Kucerova-Ruda J, Amchova P, Havlickova T, Jerabek P, Babinska Z, Kacer P, Syslova K, Sulcova A, Sustkova-
Fiserova M (The World Journal of Biological Psychiatry; IF = 4,18) - 2013 - Ghrelin receptor antagonism attenuates morphine-induced accumbens dopamine release and
behavioral stimulation in rats Sustkova-Fiserova M, Jerabek P, Havlickova T, Kacer P, Krsiak M
(Psychopharmacology; IF = 3,88) - 2011 - Pharmacological modulation of the micturition pattern in normal and cyclophosphamide-pretreated
conscious rats; Andersson M, Aronsson P, Giglio D, Wilhelmson A, Jerabek P, Tobin G (Autonomic
Neuroscience-basic and clinical; IF=1,671)
Timeline
Head of Quality Assurance
SensiQure
02.2023 - Current
Co-founder, Director of Reg. & Scientific Affairs
Herbology Ventures
02.2023 - Current
Senior Quality Assurance Consultant
TRUSTT
01.2023 - Current
Senior Quality Assurance Specialist
Tilray
08.2018 - 02.2022
International Cannabis Auditor
International Cannabis and Cannabinoids Institute (ICCI)
01.2018 - 07.2018
International CRO Manager
PharmInvent
09.2017 - 07.2018
Quality Assurance Specialist, Auditor
PharmInvent
05.2017 - 08.2017
Regulatory Affairs Specialist
PharmInvent
01.2017 - 07.2018
Medical Cannabis Specialist
State Institute for Drug Control (SÚKL)
11.2016 - 04.2017
Inspector In Quality Assurance
State Institute for Drug Control (SÚKL)
05.2014 - 10.2016
Ph.D. - Pharmacology And Toxicology
3rd Faculty of Medicine, Charles University
10.2011 - 10.2019
Co-owner, Pharmacist
JEPHARMA
01.2007 - 04.2014
Master of Science - Pharmacy
Faculty of Pharmacy, Charles University
10.2002 - 10.2006