Barbara K.

Validation specialist with 14+ years in Pharmaceuticals & Medical Devices manufacturing

Germany
English, Polish

I am a very open-minded person with skills to quickly learn and adapt to new environments. I am very self-driven and I am not afraid of challenges. My objective is to become a senior professional with...see more

  • Biotech, Pharma & Life Sciences
  • Healthcare
  • Wellness & Fitness
  • Medical Instruments & Supplies
  • ...

300

/hr
  • Pre-vetted expert
  • Confirmed hourly rate
  • Available on short notice

Experience

Validation Consultant

Maquet Getinge Group
4 years
Current position
Aug 2018 - Present
Remediation Project - Medical Devices working to standards: ISO 13485, ISO 18242, ISO 11658, ISO 7199, ISO 15676

Validation Specialist

West Pharmaceutical Services
1 year
Jul 2017 - Aug 2018
• Assist in development of Validation Plans and development of Installation Verification (IQ), Functional Testing (OQ) and Performance Qualifications (PQs) for equipment. • Working wi...see more

Validation Engineer

Nypro, A Jabil Company
2 years
May 2015 - Jul 2017
Jabil Healthcare, formerly Nypro, is the industry's largest provider of design, engineering, and manufacturing solutions. Jabil Healthcare serves five sectors: medical devices, diagnost...see more

QA Validation Technician

Forest Laboratories, member of Actavis Group
11 months
May 2014 - Apr 2015
Coordinate and perform validation projects and protocols in support of equipment, product, process and cleaning validation Write and review: protocols and reports(IQ, OQ, PQ, validation...see more

Analytical Chemist - Tech Transfer

Forest Laboratories, member of Actavis Group
2 years
May 2012 - May 2014
I am working in a very busy Tech transfer group, transferring in methods for new drug products form vendors across the Europe. Duties: •working to Company’s and industry’s technology t...see more

Analytical Chemist - Tech Transfer

MSD
7 months
Oct 2011 - May 2012
Method transfer and development, validation of analytical methods. Duties: •performing analytical investigative testing on products requiring technology transfers; •executing validation...see more

QC Analyst

Pfizer
9 months
Jan 2011 - Oct 2011
perform chemical analysis on in-process, finished product and stability products; analytical procedures including: dissolution testing, uv-spectroscopy, FTIR, wet chemistry techniques; ...see more

QC Analyst

Ricesteele Manufacturing Ltd
3 years
Apr 2008 - Dec 2010
perform chemical analysis on raw material, in-process, finished product and stability products; analytical procedures including dissolution testing, uv-spectroscopy, wet chemistry techn...see more

QC Admin

Gilead Sciences
10 months
Jun 2007 - Apr 2008
Lab Admin, six months, duties: Completing documentation associated with analytical results in a timely manner; maintenance of paper documents files and electronic versions in the syste...see more

QA Inspector

Gilead Sciences
10 months
Jun 2007 - Apr 2008
contract for two months, duties: checks on finished product for compliance with cGMP; filling documentation of Batch Records; performing review of manufacturing documentation (SOPs, fo...see more

Industries, roles and expertise

Industry experience

  • Medical Instruments & Supplies
  • Biotech, Pharma & Life Sciences
  • Healthcare
  • Wellness & Fitness

Role experience

  • Consulting
  • Quality