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Quality Assurance Manager & Qualified Person

Date: Jan 12, 2021

Location: Caronno Pertusella, IT, 21042

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job purpose

Manage the site quality system and support the SQH in the activities related to the Site Quality Program, the promotion of Quality Culture and Operational Excellence

Main activities and responsibilities

  • Ensures that the organization’s Quality Management System is fully applied within the area of responsibility maintaining total compliance to current GMP, GDP, Data Integrity requirements
  • Ensures adherence to environment, health and safety company requirements as well as legal obligations
  • Behaves according to company Ethical Code and company values
  • Ensures the correct approval, authorization and archiving of all GMP documentation of the plant
  • Ensures the correct application of the quality system and guarantees its monitoring and improvement
  • 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)
  • Assures the revision and approval of executed batch records for intermediates and finished products and control of the packing list for the shipment, according to the defined internal procedures,  to confirm their compliance
  • Manages customers’ audit and provides support to SQH in Authorities audit management
  • Collaborates with the Regulatory Affairs function, with SQH and with the Qualified Person, to ensure conformity, completeness and correspondence of the regulatory documentation
  • Ensures the performance of activities to support the management of supplier qualification, including approval and monitoring
  • Ensures the implementation of corrective actions resulting from inspections by external entities (authorities, customers, etc.)
  • Executes in internal inspections, ensures the annual programme and the monitoring of the implementation of corrective actions resulting from the internal inspection
  • Manages the system for implementation and approves changes, according to the "Change Control" procedure
  • Manages deviations and non-conformities found, ensuring the quality of the outgoing product and verifying the effectiveness of corrective actions taken
  • Supports customer complaints with related investigation, corrective activities, response and closure of complaints
  • Plans staff training activities based on needs
  • Coordinates technical documentation management activities
  • Ensures the execution of periodic reports (Product Quality Review) on products manufactured in the plant
  • Ensures the GMP training at the plant
  • Collaborates for tracking, trending and reporting of Quality Metrics for site
  • Supports the SQH in managing QA budget and planning for each budget year

In line with the policies of Human Resources department, ensures the motivation and development of employees, taking appropriate managerial action where necessary

Education & Experience Requirements

Education:

  • Minimum: University degree in accordance with legal requirements
  • Preferred: University degree in Chemistry, Pharmacy or CTF

Skills:

  • Ability to work cross-functionally
  • Strong Change Management capabilities
  • Strong Project Management
  • Familiar with Quality IT Systems: i.e. TrackWise
  • Experience in Inspection management

Languages:

  • Proficient English

Minimum Experience / Training required: 

  • 8-10 years work experience in Quality Assurance

The Qualified Person certificate is mandatory for this role

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.