Quality Assurance Specialist

hace 10 horas

Mar del Plata, Buenos Aires, Argentina Roche A tiempo completo

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 Roche's 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 Bachelor's 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 100'000 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.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

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