Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Sr. Specialist QA - External Quality - Small Molecules

  • Jun 2020 - Present

  Quality & Compliance:• Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.• Coordinate and provide concurrences on deviations, change controls and CAPAs.• Develop, implement, and review of SOPs for interactions with External Manufacturers.• Investigate customer product quality complaints.• Apply cGMP regulations and other international requirements to all aspects of the position.• Provide Quality oversight.• Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Quality.Release support:• Reviewing and approving executed batch packaging records (EBRs) including packaging validation and serialization.• Assessing change controls and deviations.• Preparing documentation for the RP/QP release.• Managing the creation and update of SOPs and other quality documentation related to packaging, product release and new product launches.Systems:• eLims Site Key User• SAP E2 Site Key User

• Quality Assurance Specialist

  • Mar 2019 - Jun 2020

  QA Specialist, External Quality (EQ) & Release

• Analytical Development and Quality Control

  • Jun 2012 - Feb 2019

  Release and retest for drug substance and drug product under GMPConduct of analytical transfer for Contract Manufacturing Organization (CMO)Conduct of full-stage validation for filing in phase III (Write-up of analytical ptotocols and reports)Development / optimization of analytical method on method development platformConduct of GMP stability studies or forced degradation studiesReview of maintenance / qualification documents of GMP equipmentGMP training for new employee, contact with internal/external partners (CMO/supplier/project leader/external laboratories)

• Clinical Trial Administration Specialist - Rotation

  • Jan 2018 - Mar 2018

  Job rotation: -Providing support to the Trial Managers and to the CTT in a phase II Clinical Study-Following-up and tracking of monitoring team training-Tracking contracts, Investigators CV and DoA-QC of site related documents. -Review and distributions of Investigator Sites Files

• Preformulation and Preclinical galenics

  • Dec 2010 - Jun 2012

  Daily formulation supportDevelopment of formulation for Tox studiesFully responsible for the HPLC park of the Formulation LabHPLC method development for stability of Tox formulations / HPLC troubleshooting

• Preformulation and Preclinical galenics / PhysChem group

  • Aug 2010 - Dec 2010

  HPLC analysis for solubility measurementpKa, log D, TGA, DSC, notion



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate, Medicinal Chemistry

  • Feb 2009 - Jul 2010

  Design and synthesis of bioactive molecules in the early stage research Design and synthesis of bioactive molecules in the early stage research