Senior Regulatory Compliance Specialist

Vor 4 Tagen


Stein am Rhein, Schaffhausen, Schweiz Healthcare Businesswomen's Association Vollzeit

Company Overview

We are a leading pharmaceutical company that produces high-quality medicines for patients worldwide. Our Stein Aseptics facility is one of our most important production sites, where we manufacture 40 million units of pre-filled syringes, vials, and ampules per year.

Job Description

We are seeking a highly motivated Postgraduate to join our Quality Assurance (QA) Operations Assembly & Packaging team. As a QA Operations Specialist, you will be responsible for ensuring the quality of our finished product batches in accordance with cGxP requirements and registration compliance.

Key Responsibilities

  • Execute Batch Record Review and Pack Sample Checks of finished product batches efficiently and timely.
  • Participate actively in achieving product delivery targets, including On Time Batch Approval, Supply Delivery Dates, and Batch right first time.
  • Provide QA oversight on shopfloor of manufacturing activities, including compounding, filling, visual inspection, and storage of bulk drug product.
  • SUPPORT in the evaluation and execution of investigations of deviations.

Required Skills and Qualifications

  • Bachelor or Master degree in natural sciences or pharmacy completed within the past 12 months.
  • Fluent German and very good English understanding.
  • No prior experience required, but insight into the manufacturing of medicines in the pharmaceutical industry is an advantage.

Benefits

  • Opportunity to work in a dynamic and quality-oriented team.
  • Support in professional development and growth.
  • Collaborative work environment.

Others

Please submit a cover letter that includes your motivation for the position and from when you will be available.



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