External Supplier Oversight Professional

3 hours ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

About the Job

We are seeking a highly skilled Quality Supplier Professional to join our team at PharmaRelations ApS. As a key member of our team, you will play a vital role in ensuring the highest standards of quality and compliance in our manufacturing activities.

Responsibilities:

  • You will be responsible for reviewing batch records to support batch release, ensuring compliance with Quality Systems, QTAs, and GMP/GDP requirements, and supporting complaint investigations and quality performance assessments (KPIs, risk assessments, remediation plans).
  • Your tasks will include requesting and reviewing GMP/GDP documentation and product reviews, assisting with quality issues, deviations, CAPAs, change requests, and audits, and acting as Quality Representative for supplier-related projects like tech transfers and launches.
  • You will also need to ensure that all quality systems are compliant with GMP/GDP regulations and that all suppliers meet our quality standards.

Requirements:

  • A degree in pharmaceuticals, biotech, or life sciences is required, along with 3-5 years' experience in QA operations, GMP/GDP, or production.
  • You should have a strong understanding of batch release processes and possess excellent task management and prioritization skills.
  • Fluency in English (written and spoken) is essential.


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