Quality Compliance Manager
3 settimane fa
Who we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, enabling TAPI to lead the industry based on our experience, expertise, technologies, and exceptional customer service. Our employees are at the core of our success. Headquartered in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to market. Job purpose Development and maintenance of quality programs, systems, processes and procedures that establish and enforce compliance with policies and regulations, demonstrate that the performances and Quality conform to established standard and agency guidelines regarding compliance, ensure best-practice Quality assurance programs. Compliance assurance for Quality Control activities, with particular reference to documentation management and data integrity requirements fulfillment. Main responsibilities and activities In the Quality Department we are looking for a brilliant profile reporting to the Site Quality Head with the following responsibilities and activities: Quality Compliance: Ensures compliance to site level procedures and demonstrates a solid understanding of Divisional policies by promptly addressing non-compliance issues as appropriate. In collaboration with the Site Quality Head and the Qualified Person, review of regulatory and quality compliance requirements, performance of gap assessments and establishment or improvement of SOPs covering all areas of applicability and developing and monitoring of corrective action plans where needed. Ensures local SOPs are aligned with DPs and cGMP guidelines. Supports the implementation of training for site staff on the implementation of DPs. Supports the Site Quality Head (acting as backup, if necessary) for the development and implementation of Notifications to Management (NTMs), Global Notifications to Management (GNTMs) and participates in the escalation process through completion and closure. Routinely collaborates with the global quality and compliance organization on the implementation of compliance initiatives. Collaborates with the Regulatory Affairs function, with SQH and with the Qualified Person, to ensure conformity, completeness and correspondence of the regulatory documentation. Inspection Management: Supports the management of Regulatory Authority, perform internal (self-inspection) and manage external compliance audits (including customers' audits and GRA audits), taking care of communication, tracking and resolution of observations (management of CAPA Plans related to observations). In collaboration with Site Quality Head and the Qualified Person, reports and manages performance of internal compliance audits including communication, tracking and resolution of observations. Inspection Readiness: Assesses Regulatory compliance status of the site with implementation of CAPAs to assure compliance. Supports the Site Quality Head in reviewing observations from other TEVA sites and implementation of CAPAs as appropriate. Verifies on-line compliance by coordinating random shop-floor rounds including all departments (Quality Walk Around). Compliance for Quality Control: Coordinates monitoring and/or reviewing/revising and implementing (including risk assessment and impact assessment) items required by Pharmacopoeias Compendial Updates. Supports QC Manager in suitability and equivalency studies reports documentation. Review/auditing data; routine or periodical review of audit trails. General responsibilities: Behaves according to company Ethical Code and company values. Collaborates with Site Quality Head, QP and Quality Assurance Manager to identify and implement continuous improvement opportunities. Assists the Qualified Person of the site and collaborates with the QP in the performance of the function (DL. 219 / 06 art. 52 paragraph 10 and art. 64 paragraph 3). SAFETY RESPONSIBILITY: Preposto per la sicurezza according to the Italian Law D.lgs 81 / 2008 : Person who, in accordance to professional skills and function, supervises the work and ensures the implementation of the directives received, monitoring the successful execution by workers and exercising a functional power. Requirements: At least 5 years of experience in quality management, preferably in Compliance. Scientific Degree (Chemical and/or CTF), preferably master in Regulatory. Good knowledge of computer systems. Good knowledge of Italian and English languages. Preferably: appointment by AIFA as Qualified Person. Pharmaceutical industry experience. What we offer? We try to take care of our employees, offering them small and large benefits. By way of example: Canteen. Working flexibility for Caregivers and parents. Coffee Key. Recognition Program. Welfare Platform. Health agreement with medical centers of excellence. Flexible working environment (2 days home office per week). Highly inclusive and multicultural working environment. Continuous learning and development programs (with full access to Linkedin Learning). Type of contract: long term contract. Location and working program: Rho (MI), from Monday to Friday. 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. J-18808-Ljbffr
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