* Prestigious pharmaceutical company
* 7-months project with extension possibility
About Our Client:
We are looking for a Quality Assurance Specialist to support the Integrated Downstream Quality Operations Team of our international pharmaceutical client, located in the canton of Solothurn.
Job Description
The selected candidate will be responsible for reviewing and approving GMP Engineering and Manufacturing documents during both project and operational phases of the site. This includes procedures, work instructions, CAPAs, deviations, change control, equipment, etc.
* Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations
* Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure product safety, efficacy, and purity
* Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX projects
* Takes part in Quality On-Call duty rotation for Quality
* Participates in batch record review and close out for batch release
Requirements
To be considered for this position, the ideal candidate must have:
* Bachelor's degree in Bio engineering, Biotechnology, or Pharmaceuticals
* At least 3 years of working experience in biotech manufacturing environment
* Proven experience in GMP-regulated environment, including validation processes
* Excellent command of English (both written and oral), German is an advantage
* Demonstrated ability to work autonomously with cross-functional team members
* Proficiency with Delta-V, PLM, TrackWise, and CMMS (Infor) is an advantage
* Hands-on expertise in equipment lifecycle management and production systems
What's on Offer
This is an excellent project opportunity to join a well-known and prestigious pharmaceutical company.