Quality Assurance Specialist (m/f/d)

For our client, a leading international pharmaceutical company with modern offices in the canton of Solothurn, we are currently looking for a Quality Assurance Specialist (m/f/d) to support the Integrated Downstream Quality Operations Team, to start immediately for the next 7 months.

Description

The selected candidate will be responsible for the following task area:

• Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations..,) 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 the safety, efficacy and purity of the products manufactured by our client
• Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction
• Take part of the Quality On-Call duty rotation for Quality
• Participates in batch record review and close out in the view of batch release

Profile

To be considered for this position, the ideal candidate must have:

• Successfully Bachelor`s degree, ideally in Bio engineering, Biotechnology or Pharmaceuticals
• At least minimum 3 years of working experience in the biotech manufacturing environment
• Proven experience in a GMP-regulated environment, including expertise in validation processes.
• Excellent command of English (both written and oral), German would be an advantage
• Demonstrated ability work autonomously with cross-functional team members
• Proficiency with Delta-V, PLM, TrackWise, and CMMS (Infor) is a strong advantage.
• Hands-on expertise in equipment lifecycle management and production systems.

Job Offer

Excellent project to join a well-known and prestigious pharmaceutical company.