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 are 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 areas of improvement
Minimum Requirements:
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
Experience in GMP environment within the pharmaceutical business or comparable
Experience in batch record review is strongly recommended
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
Time-management skills to deliver by agreed deadlines, as well as a high sense of responsibility
Willing to drive issue resolution
Excellent communication, writing, and presentation skills
Additional Information:
You will work in an international environment
A very renowned company
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