Senior Pharmaceutical Operations Specialist

15 hours ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Company Overview:

PharmaRelations ApS is a leading company in the pharmaceutical industry, committed to delivering high-quality products and services.

We are seeking a highly skilled Senior Pharmaceutical Operations Specialist to join our team.

Job Description:

  • Ensure compliance with GMP/GDP regulations by reviewing batch records and quality systems.
  • Support complaint investigations, quality performance assessments, and remediation plans.
  • Request and review GMP/GDP documentation and product reviews.
  • Collaborate with cross-functional teams to ensure quality standards are met.

Required Skills and Qualifications:

  • Degree in pharmaceuticals, biotech, or life sciences.
  • 3-5 years' experience in QA operations, GMP/GDP, or production.
  • Strong task management and prioritization skills.
  • Fluent in English (written and spoken).

Key Responsibilities:

  • Review batch records to support batch release.
  • Ensure compliance with Quality Systems, QTAs, and GMP/GDP requirements.
  • Support complaint investigations and quality performance assessments (KPIs, risk assessments, remediation plans).
  • Request and review GMP/GDP documentation and product reviews.
  • Assist with quality issues, deviations, CAPAs, change requests, and audits.
  • Act as Quality Representative for supplier-related projects like tech transfers and launches.


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