AbbVie Polska Sp. z o.o.

Quality Specialist

AbbVie Polska Sp. z o.o.O firmie

  • Warszawa, mazowieckie

  • Ogłoszenie wygasło 8 dni temu
  • Specjalista

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 29,000 people worldwide and markets medicines in more than 170 countries

Quality Specialist
Salary:
Location: Warszawa

Job Description:

  • Perform assessments to determine compliance to corporate processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Assist with the integration and support of quality regulations: drug, biologic, device and/or combination products.
  • Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.  Assist project teams in planning, preparation, review and approval of quality documentation.
  • Ensure metrics and KPIs are being met. Support in evaluation, analyze and trending quality indicators, data and performance metrics.
  • Partner, coordinate and support activities related to quality events (quality defects, security events, recalls etc) in the affiliate. Coordinate and investigate quality events such as deviations, non-conformance, product complaints and corresponding action plans including decisions.
  • Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. Responsible for carrying out a quality self-inspection program within the affiliate.
  • Responsible for Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements.
  • Coordinate the Management Review and Quality Planning processes at the affiliate.
  • Represent affiliate QA in local, regional, global and cross functional teams, projects and programs, as assigned by management.

Qualifications:

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
  • 3+ years’ experience in quality assurance, quality oversight or relevant experience.
  • Technical knowledge preferred in the following areas: Quality, Regulatory, Process Sciences, Manufacturing Operations. 
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
  • Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Strong oral and written communication skills.
  • Proficiency in English.
  • Computer skills.

If you are interested in our offer, please send in your application by Aplikuj button. Please send cv in English only.

Apply

Clause of consent to the processing of personal data for the purpose of future recruitment processes.

If you want us to keep your CV in our database, please insert the following additional consent in your CV: “I consent to have the personal data contained in my job application processed by AbbVie for the purpose of future recruitment processes”.

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 29,000 people worldwide and markets medicines in more than 170 countries

Quality Specialist
Location: Warszawa

Job Description:

  • Perform assessments to determine compliance to corporate processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Assist with the integration and support of quality regulations: drug, biologic, device and/or combination products.
  • Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.  Assist project teams in planning, preparation, review and approval of quality documentation.
  • Ensure metrics and KPIs are being met. Support in evaluation, analyze and trending quality indicators, data and performance metrics.
  • Partner, coordinate and support activities related to quality events (quality defects, security events, recalls etc) in the affiliate. Coordinate and investigate quality events such as deviations, non-conformance, product complaints and corresponding action plans including decisions.
  • Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. Responsible for carrying out a quality self-inspection program within the affiliate.
  • Responsible for Quality management of supplier qualification program including performance monitoring for key suppliers and update of Quality Technical Agreements.
  • Coordinate the Management Review and Quality Planning processes at the affiliate.
  • Represent affiliate QA in local, regional, global and cross functional teams, projects and programs, as assigned by management.

Qualifications:

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
  • 3+ years’ experience in quality assurance, quality oversight or relevant experience.
  • Technical knowledge preferred in the following areas: Quality, Regulatory, Process Sciences, Manufacturing Operations. 
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
  • Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Strong oral and written communication skills.
  • Proficiency in English.
  • Computer skills.

If you are interested in our offer, please send in your application by Aplikuj button. Please send cv in English only.

Clause of consent to the processing of personal data for the purpose of future recruitment processes.

If you want us to keep your CV in our database, please insert the following additional consent in your CV: “I consent to have the personal data contained in my job application processed by AbbVie for the purpose of future recruitment processes”.

Ogłoszenie archiwalne

Pracodawca zakończył zbieranie zgłoszeń na tę ofertę

Aktualne oferty pracodawcy