Experience

Eurofins Spinnovation Analytical

• Netherlands
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Officer

  • Jan 2018 - Present



Mead Johnson Nutrition

• Philippines
• Consumer Goods
• 700 & Above Employee

• Non Conformity & Release Officer

  • Apr 2015 - Jan 2018

  • Evaluation deviations of raw materials, semi manufactures and final products. Coordinate more investigation of the deviations root cause analyses and CAPA’s internal and external. • Take care of the processes by more investigation of the deviation. To prevent delay of release of raw materials (included packaging material), semi manufactures and final products. • Prevent unreleased final product reach the market. • Investigate root cause of market complaints and the perform preventive action to prevent recurrence Show less



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical lead / Study director at Merck Sharp and Dome

  • Sep 2007 - 2015

  Analytical Lead / Study director for several drug development projects (drug substance and drug product). • Reporting analytical results (e.g development and validation, stability / shelf life) for internal use and external use (e.g registration, filing for clinical studies) • Take care of analytical release of drug products, drug substances and impurities within project time lines. • Coordination and coaching of analytical activities within the lab and outsourcing of activities to contract labs • Verification of method development and validation, GMP releases and analyses of stability samples • Knowledge of GMP aspects and deviation & change procedures Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Aug 2001 - Sep 2007

  • Method development and validation of analytical methods (HPLC, UPLC) • Identification of API’s, impurities and degradants (HPLC-UV, UPLC and HPLC-MS) • Analyses of GMP releases and stability samples (HPLC, UPLC, GC-headspace and KF) • Visual determination of color, appearance and visible impurities • Cleaning validations and cross contamination analyses (HPLC, KF and TOC) • Correct data handling according to GMP guidance • Method development and validation of analytical methods (HPLC, UPLC) • Identification of API’s, impurities and degradants (HPLC-UV, UPLC and HPLC-MS) • Analyses of GMP releases and stability samples (HPLC, UPLC, GC-headspace and KF) • Visual determination of color, appearance and visible impurities • Cleaning validations and cross contamination analyses (HPLC, KF and TOC) • Correct data handling according to GMP guidance