Randstad Professionals is looking for several Quality Assurance Associate for a major client based in Solothurn.
Start date : ASAP, negotiable
Contract period : 6 - 12 months, extension possible
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.
The position needs 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.
This position will support quality key metrics and analysis.
This role is expected to be cross-functional between the Manufacturing Site Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.
As such, the position is expected to have 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 or Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage.
As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.
If you are interested to take on these responsibilities you should have the following requirements :
Must have is expert Level experience in cell culture , purifications process , operations and business processes within a GMP Biotech environment.
Dual Language preferred with preferences for German and English.
Experience in participating in pharmaceutical technology transfer team
Experience in the qualification of facilities, utilities , equipment and processes
Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
Candidates with experience in drug substance (or API) and drug product are preferred.
Should have 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 and ability to communicate with all levels of management, peers, contractors and external partners effectively
Demonstrated problem solving skills
Ability to work in shift model including during the weekend
Prior experience with facility construction and start-up is an asset.
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.