qa associate in Luterbach

posted
contact
Olivier Worch, Basel Professionals Health Care & Life Sciences
job type
temporary
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job details

posted
location
luterbach, solothurn
sector
life sciences
job type
temporary
reference number
15134
contact
olivier worch, basel professionals health care & life sciences
phone
058 201 55 50

job description

Randstad Professionals is looking for a QA Associate for a major client based in Luterbach.

 

Contract period: 5 months

Start date: ASAP latest 01.03.2021

The QA Operations Associate  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. 

 

Your responsibilities:

  • Reactive support of discrepancy identification, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances

  • The holder will 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

  • This role is expected to be 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.

If you are interested to take on these responsibilities you should have the following requirements:

  • 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

  • beneficial to have experience with LEAN, Six Sigma and continuous improvements

  • Strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)

  • 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

  • Good oral and written communication skills in English and German (preferred) 

  • Ability to communicate with all levels of management, peers, contractors and external partners effectively

  • Demonstrated problem solving skills

  • Prior experience with facility construction and start-up is an asset.

  • Candidates with experience in drug substance (or API) and drug product are preferred.

  • Ability to work in shift model including during the weekend

  • Experience in participating in pharmaceutical technology transfer team

  • Experience in the qualification of facilities, utilities , equipment and processes

 

We can offer you a new challenge in a diverse, innovative and multicultural environment. Have we sparked your interest? Then we look forward to receiving your online application.

Please note a Swiss Work permit or EU-citizenship is mandatory for this position.