QA Associate (m/f/d)

REFERENCE NUMBER:

464971/1

MY DUTIES:

- The QA Operations Associate III assures that all operations meet or exceed cGMP regulations 
- Ensuring the quality Bulk Drug Substance, cell bank supporting on shop floor the daily manufacturing,Warehouse and facility operations
- Reactive 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

This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures - Support quality key metrics and analysis

- You are cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner

departments

MY QUALIFICATIONS:

- Dual Language preferred with a preferences for German and English
- Prior experience with facility construction and start-up is an asset
- Proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems
- Demonstrated ability to work autonomously and lead project 
- Expert level knowledge in cell culture , purifications process 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
- 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 
- Strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.) 
- Experience in drug substance (or API) and drug product is preferred
- Experience in participating in pharmaceutical technology transfer team 
- Experience in the qualification of facilities, utilities , equipment and processes
- It will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements

MY BENEFITS:

- You will work in an international environment
- Professional and trusting cooperation
- Flat hierarchies
- Fascinating, innovative environment in an international atmosphere

ABOUT HAYS:

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
Marija Tomas

Reference number
464971/1

Contact
E-Mail: [email protected]