Operational Quality Assurance Specialist

vor 1 Monat


Bern, Bern, Schweiz Gi Life Sciences Vollzeit

About Gi Life Sciences:

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We are a leading partner in the biotechnology industry, dedicated to delivering innovative solutions and services.

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Job Title: Operational Quality Assurance Specialist

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We are seeking an experienced Operational Quality Assurance Specialist to join our team in ensuring the highest standards of quality and operational efficiency.

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Key Responsibilities:

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  • Support Operational Readiness: Collaborate with cross-functional teams to ensure seamless operational readiness for new product introductions.">
  • Daily Support: Provide daily support to the manufacturing area, including compliance, KPIs, and equipment daily checks.">
  • Equipment Qualification: Assist in equipment qualification activities to maintain high-quality standards.">
  • Manufacturing Operations: Participate in the manufacturing of Upstream or Downstream manufacturing process operations.">
  • Change Management: Author change controls and participate in deviation management, including CAPAs.">
  • Root Cause Analysis: Lead root cause analysis investigations to identify and implement corrective actions.">
  • Procedure Development: Author Standard Operating Procedures (SOPs) and Work Instructions (WIs).">
  • Risk Management: Engage in process FMEAs and Risk Analysis meetings to ensure risk mitigation.">
  • Safety Documents: Ensure required safety documents are in place for key process equipment.">
  • Training: Develop training curricula and conduct hands-on training for team members.">
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Requirements:

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  • Education: University degree in Pharmacy, Chemistry, or a relevant field.">
  • Experience: Experience in a similar position in a GMP environment.">
  • Language Skills: Fluent in English, French, and/or German (a plus).">
  • Availability: Willingness to work shifts as needed.">
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Compensation:

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The estimated salary for this role is $70,000 - $90,000 per year, depending on experience.

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Growth Opportunities:

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Gi Life Sciences offers a dynamic and supportive work environment with opportunities for growth and professional development.



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