Cecilie Hurup Munkbøl
QA/RA Manager at Vivostat A/S- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
-
Danish -
-
English -
Topline Score
Bio
Experience
-
Vivostat A/S
-
Denmark
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
QA/RA Manager
-
Nov 2019 - Present
-
-
-
Faculty of Pharmaceutical Sciences, University of Copenhagen
-
Denmark
-
Pharmaceutical Manufacturing
-
1 - 100 Employee
-
Postdoc
-
Aug 2018 - Nov 2019
-
-
-
Københavns Universitet - University of Copenhagen
-
Denmark
-
Research
-
700 & Above Employee
-
Ph.D student
-
Mar 2013 - Feb 2018
Pharmaceuticals as Endocrine disruptors - antidepressants and statins as model drug classes Pharmaceuticals as Endocrine disruptors - antidepressants and statins as model drug classes
-
-
-
UC Irvine
-
United States
-
Higher Education
-
700 & Above Employee
-
Visiting Scholar
-
May 2014 - Aug 2014
-
-
-
Thermo Fisher Scientific
-
United States
-
Biotechnology Research
-
700 & Above Employee
-
QA/RA specialist
-
Jan 2012 - Feb 2013
Main responsibilities: • Responsible for establishing and maintaining regulatory documentation • Preparation of standard procedures • Performer of both internal • Complaint handling • Responsible for setting up the server system • Responsible for setting up system for customer requests • Supporting other site within the organization Main responsibilities: • Responsible for establishing and maintaining regulatory documentation • Preparation of standard procedures • Performer of both internal • Complaint handling • Responsible for setting up the server system • Responsible for setting up system for customer requests • Supporting other site within the organization
-
-
-
Jemo-pharm A/S
-
Alternative Medicine
-
1 - 100 Employee
-
QP
-
Jul 2011 - Dec 2011
Main responsiblities:• Release of raw materials, excipients and intermediates and finished goods - pharmaceuticals• Responsible for Jemo-Pharms internal audits• Responsible for product qualification reports (PQR)• Responsible for qualification and validation of production equipments• Preparation of standard operating procedures• Responsible for cleaning validation• Preparation of raw material, excipients and finished goods specifications• Performing external audits at manufactures of raw materials and contract laboratories• Answering questions from authorities and external partners• Support to production• Support to regulatory affairs (RA)• General maintenance of GMP-rules in the company Show less
-
-
QA
-
Aug 2010 - Jul 2011
Main responsibilities:• Release of raw materials, excipients, bulk- and finished goods-food stuff• Preparation of raw material, excipients and finished goods specifications• Responsible for PQR• Responsible for qualification and validation of production equipments• Responsible for complaints and recalls• Responsible for handling deviations • Answering questions from external partners• Support to productionGeneral maintenance of GMP-rules in the company
-
-
-
Københavns Universitet - University of Copenhagen
-
Denmark
-
Research
-
700 & Above Employee
-
Thesis student
-
Feb 2010 - Aug 2010
Project title: Individual and combined effects of three well-known endocrine disruptors on the steroidogenesis in the H295R cells Project title: Individual and combined effects of three well-known endocrine disruptors on the steroidogenesis in the H295R cells
-
-
-
-
Stud pharm
-
Jun 2009 - Jul 2010
• Advise and guide clients at the counter • Receipt of telephone prescription • Consult with physicians in relation to changing of prescription or other questions • Several expeditions in English • Advise and guide clients at the counter • Receipt of telephone prescription • Consult with physicians in relation to changing of prescription or other questions • Several expeditions in English
-
-
-
-
Office girl
-
Jan 2007 - Sep 2009
-
-
-
-
Waitress/student worker
-
Jan 2001 - Jan 2007
-
-
Education
-
Danmarks Farmaceutiske Universitet
cand. Pharm., Toxicology -
Danmarks Farmaceutiske Universitet
Cand Pharm, Mathematical student