Beschreibung
Quality Assurance Associate (m/f/d)
Reference: -en
Start: asap
Duration: 5 MM+
Main tasks:
- Assure all operations meet or exceed cGMP regulations / ensure high level of quality of Bulk Drug Substance
- Provide Quality Assurance input and oversight for manufacturing process and logistics management as such warehousing and shipping.
- Root cause analysis and corrective action for product and process related non-conformances as SME Q for minor, major and critical deviation
- Collect data for metrics and identification of negative trends
- Support as QA SME implementation of project
- Standard Operating Procedures review, revision & approval
- Process design and improvement
- Support on product quality impact assessment (PQIA) and process/product risk assessment
- Support on management of Project implementation (e.g. New Product introduction)
Main qualifications
- Expert level knowledge in operations and business processes within a GMP Biotech environment.
- Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage
- Dual Language preferred with a preferences for German and English
- Prior experience with facility construction and start-up strongly preferred
- Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems
- Candidates with experience in drug substance (or API) and drug product are preferred
- Experience in participating in pharmaceutical technology transfer team
- Basic experience in the qualification of facilities, utilities , equipment and processes
- Beneficial to have experience with LEAN, Six Sigma and continuous improvements (high-throughput facility)
Main advantages:
- Reputable international company
About us:
With over 15 years of experience in the pharmaceutical industry, 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 professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
Referencenumber:
Make contact:
Email: