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Senior Compliance Specialist

Date: Jun 9, 2021

Location: Rho, IT, 0000

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

 

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 with particular reference to suppliers qualification / management, regulatory affairs and R&D support, inspections management and internal audit program execution. 

Main Activities and Responsibilities

 

Quality Assurance area:

 

  • Quality Systems Management and Compliance:
    • Demonstrates good general understanding of the standards and regulatory bodies that regulate our industry.
    • Ensures compliance to site level procedures and demonstrates a solid understanding of Divisional policies and Corporate standards by promptly addressing noncompliance issues as appropriate.
    • Ensures adherence and maintains the effectiveness of the Quality System. In collaboration with the Site Quality Head and the Qualified Person, review of regulatory and quality compliance requirements and corporate standards, 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 performance and resolution of complex investigations for deviations and complaints. 
    • Ensures evaluation of product safety and efficacy and elevation of risk-based issues, creating / reviewing risk management documentation. Issues risk control documentation, demonstrating ability to analyze, evaluate and manage risk.
    • Supports the Site Quality Head (acting as back up, if necessary) 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.
    • Verifies on line compliance by means of random shop floor rounds including all departments (Quality Walk Around).

 

  • Inspection Management:
    • Supports the management of Regulatory Authority and other internal (self-inspection/GRA)/external compliance audits (including customers’ 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.

 

  • Supplier Qualification and Management:
    • Oversight, review, and approval of suppliers and materials for use in production and processes (vendor audits, QTAs, vendor related deviations investigations, vendor/Material change controls).

 

  • Regulatory Affairs and R&D support:
    • Provide supporting information to Regulatory Affairs (as example, DMF/CEP submission/DL management/ etc) and R&D/MS&T (technology transfer / submissions new market / DL) departments.

 

Customer Service area:

  • Supports as quality interface with internal and external customers when dealing with activities such as QTAs, supplier qualification, issue resolution, complaints, product information and customers’ specification.

Qualifications

 

Education:

  • Bachelor’s degree in Chemistry, Pharmacy, Life Sciences or closely related discipline is required.

 

Skills:

  • Able to work with a good level of autonomy with supervision where necessary
  • Ability to work cross-functionally.
  • Familiar with Quality IT Systems: i.e. TrackWise

 

Languages:

  • Italian, good command of English is a strong preference

 

Minimum Experience / Training required: 

  • At least 5 years work experience in Quality or related field experience is required.
  • Preferred experience in the API Industry, Regulatory Affairs, Suppliers Qualification/Management.

Function

Quality

Sub Function

Manufacturing Quality Assurance

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.