Quality Assurance Specialist

Roche

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profile Job Location:

Buenos Aires - Argentina

profile Monthly Salary: Not Disclosed
Posted on: 21 hours ago
Vacancies: 1 Vacancy

Job Summary

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

As a Quality Assurance Specialist (GMP) at Roche you will play a critical role in safeguarding product quality regulatory compliance and patient safety across local affiliate operations. You will contribute to the strength and effectiveness of the Pharmaceutical Quality System ensuring that both commercial and clinical trial products are released and managed under the highest GMP and regulatory standards. Acting as a trusted quality partner across the supply chain you will support continuous improvement initiatives and reinforce Roches commitment to delivering safe high-quality medicines to patients.

The Opportunity

  • Ensure GMP compliance across warehouse and distribution operations in line with Roche standards and regulatory requirements.

  • Review compile and manage product release documentation including materials submitted to Health Authorities.

  • Administer and maintain the local SOP management system (Veeva Docs) ensuring procedures are current controlled and accessible.

  • Manage quality events (deviations non-conformities CAPAs and change controls) ensuring timely investigation closure and cross-functional accountability.

  • Participate actively in self-inspections audits supplier qualifications and regulatory inspections including first-batch and GMP inspections.

  • Provide technical quality support for complaints inquiries recalls and risk assessments documenting activities in Veeva Vault OneQMS.

  • Support the local implementation of global PQS documentation and contribute to cross-affiliate quality collaboration when required.

Who You Are

  • You hold a Bachelors degree in Pharmacy (or equivalent scientific discipline) and have experience in GMP-regulated environments.

  • You bring a strong quality mindset with attention to detail integrity and a clear focus on patient safety.

  • You are organized autonomous and able to manage multiple priorities effectively in a regulated fast-paced setting.

  • You demonstrate strong communication and stakeholder management skills working confidently across cross-functional teams.

  • You are proactive and improvement-oriented with the ability to act with urgency while maintaining full compliance.

This position does not offer relocation benefits.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.


Lets build a healthier future together.

Roche is an Equal Opportunity Employer.


Required Experience:

IC

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim...
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About Company

F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.

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