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Senior Quality Assurance Specialist

Date: Jan 12, 2021

Location: Assago, IT, 20090

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

Support Commercial Quality activities, in alignment with Business Unit, in order to promote quality culture through information and application of the rules, policies and procedures in order to ensure products are efficiently distributed into the country by meeting Teva, regional and local standards and customer needs

Responsibilities

Support Commercial Quality activities in order to ensure products are efficiently distributed into the country by meeting Teva, regional and local standards and customer needs

Main activities

1) Local Quality System deployment

  • Ensure GMP & GDP compliance at the Commercial Unit and promote quality culture
  • Support creation maintaining up-to-date and distribution of Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations
  • Support to ensure GMP and GDP training at a local level
  • Initiate continuous improvement of processes
  • Contribute to Lead the Local Cross functional Quality Council
  • If applicable, ensure a system is in place to manage and review Product Quality Reviews for local products
  • Attend to European monthly Quality Councils as back-up
  • Provide the relevant data to the European Commercial Quality local monthly quality metrics

2) Operational implementation Quality Management System (QMS)

  • Market release: ensure market release from approved suppliers based on batch release documentation and transport conditions documentation
  • Distribution

- Cooperate to ensure GDP compliance of the distribution center(s)
- Review documentation related to returned goods in order to evaluate if units can be approved to saleable stock ensuring the distribution traceability of finished products and returns of products commercialized in the country
- Support to evaluate final disposition of rejected, recalled or falsified products

  • Complaints and Recalls

- Ensure quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary
- In case of recall, support to ensure local coordination between PhV, Medical Affairs, Regulatory Affairs, Supply Chain, etc. and with EU Qualified Person concerned. Escalate any critical information to Commercial Quality Head and issue the final recall report

  • Change control, deviations and CAPAs: support change control, deviation and CAPA handling
  • Suppliers/customers and 3rd Party service providers (in cooperation with TPO team):

- Maintain and monitor a list of approved suppliers/customers/providers
- Ensure Quality Agreements are drawn up and kept updated with all local suppliers/customers and 3rd Party service providers as required

  • Archiving: archive relevant quality related documentation as required

3) Critical Quality Incidents

  • Escalate to Commercial Quality Head critical quality issues raised at local level
  • Support to ensure local deployment of action plan related to quality incidents
  • Support to ensure appropriate communication with local Competent authorities

4) Authorities Inspection readiness

  • Support to ensure permanent authorities inspection readiness in the country
  • Support to define inspection CAPA plan
  • Support to ensure inspection CAPA plan defined is deployed in due date
  • Support self-inspection plan in order they are performed at regular intervals

5) Business support

  • Establish network with other supportive functions (Supply chain, Regulatory Affairs, etc.)

6) Support Teva and Quality strategic business initiatives

  • Participate to the execution of projects coordinated in the country, as applicable

Education & Experience Requirements

Education Required

  • Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role

Experience Required

  • Minimum of 5 years’ experience in a pharmaceutical company or importer/distributor

Specialized or Technical Knowledge Licenses, Certifications needed

  • Knowledge and working experience with government regulations for the country
  • Knowledge of pharmaceutical industry as it relates to Quality Compliance
  • Working knowledge of pharmaceutical operations
  • Understanding of GxP's regulations
  • Knowledge of risk assessment tools
  • Good computer skills in current software including MS Office
  • Good English

Skills & Competencies

Technical & Professional Expertise

  • Result-driven
  • Determine stakeholders needs and expectations
  • Ability to adhere determined timelines

Problem Solving

  • Gather and assess relevant information, using abstract ideas to interpret it effectively
  • Open minded, creative thinking to create the most efficient solutions

Autonomy & Independence

  • Demonstrate initiative and creates an appropriate level of urgency to meet objectives and deadlines
  • Able to learn independently
  • Adaptability and stress tolerant; organized, execute with the ability to be agile and flexible even under adverse circumstances
  • Understand when a problem needs to be escalated

Communication, Collaboration & influencing

  • Actively collaborate and cooperate with others
  • Establish and maintain professional relationships within the organization
  • Ability to work within a team
  • Demonstrate good oral and written skills
  • Good Presentation skills

    For this position, the company offers a fixed term contract of 6 months

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.