Operational Quality Assurance Specialist

vor 1 Woche


Bern, Bern, Schweiz Gi Life Sciences Vollzeit

Gi Life Sciences is seeking an experienced Operational Quality Assurance Specialist to support the operational readiness of new product introductions in our biotechnology industry.

We offer a competitive salary, commensurate with experience and qualifications. Estimated annual salary: $80,000 - $110,000.

Job Description:

  • Operational Readiness: Support the daily operations of our manufacturing area, ensuring compliance with USP and DSP standards, tracking key performance indicators (KPIs), and scheduling daily activities such as material staging and equipment checks.
  • Equipment Qualification: Collaborate with cross-functional teams to ensure equipment qualification activities are completed efficiently and effectively.
  • Manufacturing Operations: Participate in the production process, either upstream or downstream, and contribute to change management initiatives, deviation management, and root cause analysis investigations.
  • Documentation and Training: Author Standard Operating Procedures (SOPs) and Work Instructions (WIs), lead training sessions for team members, and develop curricula for hands-on training.
  • Process Improvement: Engage in FMEA and risk analysis meetings to identify areas for improvement and implement corrective actions.

Your Profile:

  • Education: University degree in Pharmacy, Chemistry, or relevant field.
  • Experience: Proven track record in a similar role within a GMP environment.
  • Language Skills: Fluent in English; proficiency in French and/or German is a plus.
  • Availability: Willingness to work flexible hours, including shifts, if required.


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