Corporate Quality Assurance Specialist

Há 1 mês


Santana de Parnaíba, São Paulo, Brasil Chiesi Farmaceutici S.p.A. Tempo inteiro
About Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici S.p.A. is a leading international pharmaceutical and healthcare company with over 85 years of experience. We operate in 31 countries and have a global presence with over 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.

Job Summary

We are seeking a highly skilled and experienced Corporate QA Senior Specialist to join our team. The successful candidate will be responsible for managing products/projects related to the respiratory area from a qualitative and analytical point of view. This is a challenging and rewarding role that requires strong leadership and collaboration skills.

Main Responsibilities
  • Manage products/projects related to the respiratory area from a qualitative and analytical point of view.
  • Collaborate with other functions both locally and at Corporate level, interfacing with R&D, regulatory functions, and external consultants.
  • Implement guidelines for system and process validation activities in compliance with National and International GMP regulations.
  • Supervise validation activities at Chiesi sites by evaluating data and defining corrective actions with local teams.
  • Collaborate in the drafting and preparation of validation documents relating to Corporate products and/or new lines/departments at Chiesi production sites.
  • Manage change control and deviations relating to Corporate products/processes.
  • Provide support in strategic planning activities of the Industrial Management, including scenario analysis, business continuity risk analysis, and definition of the insourcing/outsourcing strategy in the industrial area.
  • Contribute to the drafting of Technical Agreements when defining them with suppliers of materials and services.
  • Provide support in the definition of industrialisation programmes for new products or the implementation of new production processes for products already on the market.
Requirements
  • At least 6-8 years of experience in Quality Assurance in the pharmaceutical industry.
  • Degree in Chemistry, Industrial Chemistry, CTF, Biotechnology, Biology, or equivalent.
  • Fluent knowledge of the English language; knowledge of the French language will be considered a plus.
  • Excellent knowledge of international pharmaceutical legislation and international regulatory references concerning the production, control, and distribution of drugs.
  • Knowledge of Total Quality Management standards and principles, management information systems (ERP), and suppliers and subcontractors in the Italian and possibly European sphere.
  • Knowledge of Risk Management, Auditing, and Training techniques.
What We Offer

You would join a dynamic, fast-growing, challenging, and friendly environment. We believe that our people are our most valuable asset, and we invest in continuous training, learning, and development. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being. We offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.



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