Quality Senior Supervisor Europe

Teva Pharmaceuticals PolskaO firmie

  • Kraków, małopolskie

  • Ważna jeszcze 3 dni
    do: 15 lip 2020
  • Umowa o pracę
  • Pełny etat
  • Starszy specjalista (Senior)
Grafika górna

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!

Position Summary

The Quality Supervisor Commercial Quality (CQ) is responsible for the overall support, coordination, administrative tracking plus archiving of Commercial Quality activities on Quality issues under (g)NTMs (notification to management for a critical quality issue), notification of drug shortages on EU level, monthly Quality metrics consolidation and tracking on EU level, monthly EU CQ Quality council oversight. The position will support the regional EU QMS, by participating in Standard operating procedure (SOPs)and GMP/GDP trainings preparation and CQ TeamRoom updates.

All activities are done in cooperation and alignment with European senior CQ management, in order to ensure products are efficiently distributed into the countries by meeting Teva’s, regional and local standards and customer needs, and in compliance with legal requirements.

Quality Senior Supervisor Europe
Location: Kraków

Essential Duties & Responsibilities

1. Quality issues, under (g)NTMs as critical

  • Distribute authority notification letter for critical quality issues under (g)NTMs to impacted countries and Site and track filing to authorities
  • Forward & track questions received from authorities to Site, third parties operations (TPO), CQ or management
  • Support in potential consultation of countries for the NTM before publishing
  • Coordinate impact assessment evaluation within EU CQ Units
  • Track of the (g)NTM life cycle in: Quality Alignment Meeting (QAM) date, minutes, decision, reporting to authorities, received requestes from authorities till closure
  • Keep statistics up to date on NTMs open till closed

2. Drug shortage

  • Support in completing the notification to authorities
  • Forward & track questions received from authorities to Site, Teva Pharmaceuticals Europe, CQ or management
  • Track of authority notification: reporting to authorities, received requests from authorities till closure
  • Keep statistics up to date on open drug shortage

3. Supportive tasks

  • Collect information, documentation and slides for monthly quality council
  • Participate in monthly council and draft meeting minutes
  • Collect information and data for monthly metrics and issue European metrics monthly

4. European Quality Management System (QMS)

  • Support in updating regional EU SOPs of the Commercial Quality EU QMS
  • Keep overview of annual review

5. European Quality System deployment

  • Maintain Commercial Quality Teamroom
  • Keep documentation on Teamroom up to date
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Position Requirements

Education&Experience

  • Bachelor´s Degree in Pharmacy, Biology, Healthcare or an equivalent combination of education and experience to the functional role
  • 5 years of experience within pharmaceutical industry and 3 years in a Quality Role

Specialized or Technical Knowledge Licenses, Certifications needed

  • Knowledge of pharmaceutical industry as it relates to Quality process & Compliance
  • Working knowledge of pharmaceutical operations
  • Understanding of GMP & GDP regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including MS Office
  • Excellent English
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Why TEVA?

  • Competitive salary & bonus scheme
  • Private medical care
  • Optional life insurance
  • Sports card
  • Employee reward programmes
  • Social fund benefits
  • Development within company structure
  • High organizational culture
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.

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!

Position Summary

The Quality Supervisor Commercial Quality (CQ) is responsible for the overall support, coordination, administrative tracking plus archiving of Commercial Quality activities on Quality issues under (g)NTMs (notification to management for a critical quality issue), notification of drug shortages on EU level, monthly Quality metrics consolidation and tracking on EU level, monthly EU CQ Quality council oversight. The position will support the regional EU QMS, by participating in Standard operating procedure (SOPs)and GMP/GDP trainings preparation and CQ TeamRoom updates.

All activities are done in cooperation and alignment with European senior CQ management, in order to ensure products are efficiently distributed into the countries by meeting Teva’s, regional and local standards and customer needs, and in compliance with legal requirements.

Quality Senior Supervisor Europe
Location: Kraków

Essential Duties & Responsibilities

1. Quality issues, under (g)NTMs as critical

  • Distribute authority notification letter for critical quality issues under (g)NTMs to impacted countries and Site and track filing to authorities
  • Forward & track questions received from authorities to Site, third parties operations (TPO), CQ or management
  • Support in potential consultation of countries for the NTM before publishing
  • Coordinate impact assessment evaluation within EU CQ Units
  • Track of the (g)NTM life cycle in: Quality Alignment Meeting (QAM) date, minutes, decision, reporting to authorities, received requestes from authorities till closure
  • Keep statistics up to date on NTMs open till closed

2. Drug shortage

  • Support in completing the notification to authorities
  • Forward & track questions received from authorities to Site, Teva Pharmaceuticals Europe, CQ or management
  • Track of authority notification: reporting to authorities, received requests from authorities till closure
  • Keep statistics up to date on open drug shortage

3. Supportive tasks

  • Collect information, documentation and slides for monthly quality council
  • Participate in monthly council and draft meeting minutes
  • Collect information and data for monthly metrics and issue European metrics monthly

4. European Quality Management System (QMS)

  • Support in updating regional EU SOPs of the Commercial Quality EU QMS
  • Keep overview of annual review

5. European Quality System deployment

  • Maintain Commercial Quality Teamroom
  • Keep documentation on Teamroom up to date

Position Requirements

Education&Experience

  • Bachelor´s Degree in Pharmacy, Biology, Healthcare or an equivalent combination of education and experience to the functional role
  • 5 years of experience within pharmaceutical industry and 3 years in a Quality Role

Specialized or Technical Knowledge Licenses, Certifications needed

  • Knowledge of pharmaceutical industry as it relates to Quality process & Compliance
  • Working knowledge of pharmaceutical operations
  • Understanding of GMP & GDP regulations
  • Experience with development and implementation of Quality Systems and application of risk assessment tools
  • Proficient computer skills in current software including MS Office
  • Excellent English

Why TEVA?

  • Competitive salary & bonus scheme
  • Private medical care
  • Optional life insurance
  • Sports card
  • Employee reward programmes
  • Social fund benefits
  • Development within company structure
  • High organizational culture
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.

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