Quality Assurance Specialist for Biotech Manufacturing
Vor 2 Tagen
Gi Life Sciences is seeking a highly skilled Quality Assurance Specialist to support the operational readiness of new product introduction in our biotechnology industry.
Responsibilities:- Ensure daily compliance with USP and DSP manufacturing area standards, including KPI monitoring.
- Schedule and manage daily operational activities, such as material staging and equipment checks.
- Support equipment qualification processes and participate in Upstream or Downstream manufacturing operations.
- Lead root cause analysis investigations and author Standard Operating Procedures (SOPs) and Work Instructions (WIs).
- Actively engage in process FMEAs and Risk Analysis meetings to ensure safety and quality standards.
- University degree in Pharmacy, Chemistry, or relevant field.
- Experience in a similar position within a GMP environment.
- Fluency in English, with proficiency in French and/or German a plus.
- Ability to work flexible shifts, including night and weekend rotations.
$65,000 - $85,000 per annum, depending on experience and qualifications.
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