Quality Assurance Specialist
hace 1 semana
Job Summary: Novartis is seeking a highly motivated Quality Assurance Specialist to join our Pharmaceutical Operations team in Mexico. As a key member of the team, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:
- Ensure that all aspects of product handling, manufacturing, and distribution comply with Novartis' quality manual and relevant regulatory requirements.
- Prepare, review, and check batch documentation for correctness, completeness, and safety archive original documents as per prescribed period.
- Monitor actions and corrections accordingly.
- Conduct GxP monitoring on all sections, conduct QA investigations for noncompliance, follow up corrective actions.
- Archive relative documentations and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits, and product tampering) according to the Quality Agreement and the Novartis Quality Manual.
- Ensure investigations are correctly executed.
- Escalate any issues or instances of instability per the Novartis escalation policy and initiate market action required.
Requirements: The successful candidate will have at least 2 years of experience in quality assurance, preferably in the pharmaceutical industry. Strong knowledge of GxP regulations and experience in implementing quality systems are essential. Additionally, excellent communication and problem-solving skills are required.
Benefits:
- Competitive salary range of $110,000-$140,000 USD per year, depending on qualifications and experience.
- Opportunities for professional growth and development within a global organization.
- A dynamic and diverse work environment with a focus on innovation and teamwork.
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