Beschreibung
QA Operations Associate (m/f/d)
Reference: -en
Start: asap
Duration: 7 MM++
Main tasks:
- Meet or exceed cGMP regulations ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing, Warehouse and facility operations
- Support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances
- Collaborate with product Quality Management for change control
- Direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures
- Review protocols related to Cleaning in Service of the manufacturing equipment until completion of the Cleaning validation
- Support deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs)
- Support cross functional groups on root cause analysis and corrective and preventive actions, strategy definition and processes improvement
- Provide quality oversight of change control process to support manufacturing process successful life cycle managment
- Develop and maintain the KPIs of the Solohturn QA ops department, in collobaration with Manufacturing and Operational excellence department
- Revise and approve Standard Operating Procedures, work Instructions and documentation as needed
Main qualifications
- Expert in cell culture, purifications process , operations and business processes within a GMP Biotech environment
- Experience in automated environement
- Experience in drug substance (or API) and drug product
- Experience in the qualification of facilities, utilities , equipment and processes
- Experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems
- Demonstrated ability to work autonomously
- Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Demonstrated problem solving skills
Main advantages:
- International company
- Remote work within CH
- Extension possible
About us:
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.
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