Quality Assurance Technician
hace 2 semanas
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
**SCOPE OF POSITION**:
Collaborate in the updating and maintenance of the Quality System, participating in the verification of its compliance so that the products (pharmaceuticals, health products, cosmetics and dietary supplements) are developed, registered, manufactured, evaluated, delivered to the client according to to the established requirements and guarded its post-commercialization system.
Promote quality internally as part of the Casen Recordati culture
**JOB TASKS**:
- Manage the preparation of technical and quality agreements.
- Collaborate and participate in the preparation and updating of documentation related to general activities GMP's, GDP's, GLP's, ISO 13485, Food - Food Supplements and Cosmetics.
- Review and approve the procedures, specifications and work tools of other departments, as well as the protocols that are generated, directly related to GxP areas of the products
- Review information related to the preparation of each batch of product and participate in the proposal to Technical Management for the release of the product, adjusting to the planning of activities, including the documentation file.
**RESPONSIBILITIES**
Collaboration and participation in the preparation and performance of self-inspections, audits
- Participate and prepare the study of reports resulting from areas of improvement and monitoring of CAPA actions.
- Collaborate in the preparation of quality reports related to the activity "Product Quality Review" (PQR).
- Perform other functions and participate in projects not reflected here depending on the needs of the Quality Assurance department
- Manage deviations and change controls
- At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone's contribution and achievements can be appropriately rewarded._
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