Senior Quality Assurance Manager
24 ore fa
Company Overview: TAPI is a leading international supplier of active pharmaceutical ingredients (APIs), with over 80 years of experience and a portfolio of over 350 API products. We are proud to be one of the most trusted API suppliers, enabling us to lead the industry based on our expertise, technologies, and exceptional customer service.
Job Description: We are seeking a Senior Quality Assurance Manager to join our team in Rho, Italy. As a key member of our quality department, you will be responsible for ensuring compliance with policies and regulations, demonstrating that performances and quality conform to established standards and agency guidelines. You will also ensure local SOPs are aligned with Divisional policies and cGMP guidelines.
Estimated Salary: €80,000 - €120,000 per year, depending on experience. This is a long-term contract position, working Monday to Friday.
Responsibilities:
- Develop and maintain quality programs, systems, processes, and procedures that establish and enforce compliance with policies and regulations.
- Ensure compliance to site level procedures and demonstrate a solid understanding of Divisional policies by promptly addressing non-compliance issues as appropriate.
- Review regulatory and quality compliance requirements, perform gap assessments, and establish or improve SOPs covering all areas of applicability.
- Support the implementation of training for site staff on the implementation of DPs.
- Routinely collaborate with the global quality and compliance organization on the implementation of compliance initiatives.
- Collaborate with the Regulatory Affairs function, with SQH and with the Qualified Person, to ensure conformity, completeness, and correspondence of the regulatory documentation.
- Support the management of Regulatory Authority, perform internal (self-inspection) and manage external compliance audits (including customers' audits and GRA audits).
Requirements:
- At least 5 years of experience in quality management, preferably in Compliance.
- Scientific Degree (Chemical and/or CTF), preferably a master's in Regulatory.
- Good knowledge of computer systems.
- Good knowledge of Italian and English languages.
Benefits:
- We offer a competitive salary, flexible working hours, and a highly inclusive and multicultural working environment.
- Continuous learning and development programs (with full access to Linkedin Learning).
- A comprehensive welfare package, including health insurance, gym membership, and more.
Teva's Commitment to Equal Opportunities: Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity, gender expression, protected categories, or any other legally recognized status that is entitled to protection under applicable laws.
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