Specialist Quality Assurance

Vor 6 Tagen

Lucerne Metropolitan Area, Schweiz Gi Group Vollzeit CHF 60'000 - CHF 90'000 pro Jahr

For our client, a global pharma company located nearby Lucerne, we are looking for a motivated team player as

Specialist Quality Assurance

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

In this role the QA Specialist will review batch record of clinical supplies which are packaged locally and at CMO. This position offers a thrilling cross functional work environment with multiple stakeholders in multiple countries.

Your Tasks & Responsibilities:

  • Review and release of incoming label stock
  • Review, and release of clinical finished goods, including review of the printed and applied label
  • GMP review of the batch record and review of the regulatory filings and the final release
  • Collaborate closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,)
  • Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP). This job requires a high sense of accuracy and very good time management skills which essential to ensure timely supply of the clinical drugs to patients. Prompt, professional and precise communication to local and global stakeholders is key.

Your Qualifications:

Technical Skills:

  • Bachelor's or Master's Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies. Master's Degree in clinical research, clinical data or clinical analysis is also advantageous.
  • Minimum of 2-years' experience in GMP environment within the pharmaceutical business or comparable
  • Experience in batch record review is advantageous.
  • Excellent experience with Good Documentation Practices
  • Demonstrated problem-solving skills, preferably with Six Sigma Tools
  • Preferably SAP and MS Word/Excel Experience
  • English and German language – Proficiency at a business level is necessary.

Personal competences:

  • Time management skills to deliver by agreed deadlines, as well as high sense of responsibility.
  • Willing to drive issue resolution
  • Excellent communication, writing, and presentation skills.
  • Demonstrated ability to effectively collaborate and influence internal and external stakeholders.
  • Excellent analytical and problem-solving skills.
  • Excellent team player

Your Application:

Please apply online. For further information about the position, please contact your Gi consultant,
Nicolas Keller
, MSc Biochemistry ;

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