
Senior Pharmaceutical Operations Specialist
15 hours ago
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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