Specialist Quality Assurance (m/w/d)

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• 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.
• Logbook reviews
• Support in Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensure quality compliance and/or identify potential area of improvements.

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 strongly reccomended
• 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