Specialist Quality Assurance (m/f/d)
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.
- 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
Profile
- 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 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.
- 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
Benefits
- You will work in an international environment
- A very renowned company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
+41 44 225 50 00© Copyright Hays plc, . Ordet HAYS, H-enhederne, „Hays Working for your tomorrow" og „Powering the world of work" og tilhørende logoer og illustrationer er varemærker tilhørende Hays PLC. H-enhederne er originale designs, der er designbeskyttede i mange lande. Alle rettigheder er forbeholdt.