The opportunity
As a Quality Control Analyst, you'll be responsible for ensuring the quality and compliance of our pharmaceutical products. Your key duties will include conducting detailed analyses, implementing new/updating test methods, and ensuring adherence to national and international quality standards such as cGXP, pharmacopoeia guidelines, and Teva Global standards.
Next to that you will identify deviations, investigate root causes, and proposing corrective actions to uphold product quality and regulatory compliance.
Will you be part of our Compliance, Stability and Investigations team?
How you’ll spend your day
Execute the implementation of and compliance with national and international quality standards (cGXP), pharmacopoeial guidelines and Teva Global standards
Timely implementation of validated Analytical methods.
Execute the review and implementation of Teva standards and procedures at the department.
Maintain adherence to corporate policies and appropriate regulations through actions and decisions.
Initiates corrective action as soon as deficiency is identified; completes checklist and other information sheets required and coordinates on-site inspection of sections for which responsible.
Write assessments, study protocols and reports as part of failure investigations or method updates, validations and/or verifications.
Testing and evaluation of quality of active ingredients and drug products throughout manufacturing process and during shelf life of the drug product (stability testing).
Maintain quality at the lab in accordance with site SOP's, regulatory guidelines and cGXP compliance requirements.
Participate in the change controlled quality management system for changes, deviations and out of specification results.
Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
Execute all work according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems.
Preparation of documents that report the results of own lab work.
Give support during regulatory and compliance audits.
