Responsible for Teva api cGMP compliance by supporting the Teva api sites in the network: inspection readiness, execution and follow up of audits, investigations, risk assessments and maintaining Teva api Quality Management System.
Required to travel regularly; up to 50 % of the time.
Co-ordinate with the relevant SQHs around inspection readiness
Attends Regulatory Audits in the Teva api network as representative of Teva api Global Compliance.
Prepare and Review audit responses to Regulatory Audits of the Teva api sites and follow up.
Update and renew Teva api divisional policies as part of the Teva api Quality Management System (QMS)
Review investigations, Risk Assessments of Teva api sites
Continually improve and implement processes that will enhance the Teva api Quality Management system.
Develop metrics and targets that will assist Teva api sites to stay compliant.
Requirements:
Bachelor/Master degree of science (Chemistry) or Pharmaceutical Sciences, Business, Healthcare or an equivalent combination of education and experience for the functional role.
Minimum of 5 years of experience in Quality function
Demonstrated knowledge and working experience with GMP
Working knowledge of API manufacturing operations.
In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance.
Fluently in written and spoken English.
Ability to clearly and effectively communicate with all levels in the organization as well as with external customers.
Strong analytical, planning and thinking skills.
Collaborate with other stakeholders in the organization