Expoint - all jobs in one place

המקום בו המומחים והחברות הטובות ביותר נפגשים

Limitless High-tech career opportunities - Expoint

Teva Sr Manager Quality Assurance 
Malaysia, Penang, George Town 
481554687

11.08.2024
The opportunity
  • Inspection Readiness Expert with extensive experience in audit and compliance within the pharmaceutical industry.
  • Responsible for ensuring site readiness and regulatory compliance by overseeing and managing audits, assessing vendor compliance, and providing remediation actions.
  • This role requires a deep understanding of regulatory requirements and Pharmaceutical standards, as well as the ability to effectively prepare and review risk assessments and Corrective and Preventive Actions (CAPA).
How you’ll spend your day
  • Evaluate vendor and site compliance, including reviewing risk assessments of audit deficiencies, corrective and preventive actions, and overall compliance status.
  • Develop and monitor the implementation of remediation actions to address audit findings and ensure ongoing compliance.
  • Communicate potential risks and impacts related to site observations and GMP deficiencies to relevant stakeholders.
  • Prepare and review risk assessments and CAPA plans based on audit results and site observations.
  • Support the process for notifying management of critical and major findings
  • Regularly participate in internal and external training sessions to stay current with industry standards and best practices.
  • Must be able to travel approximately 50% of the time.
Your experience and qualifications
  • Post Graduate /Graduate in Science.
  • Minimum 15 years of experience required in Quality assurance specifically in Compliance and auditing in a regulated pharmaceutical environment.
Reports To

Associate Director QA