Operational Quality Assurance Specialist
vor 1 Monat
About Gi Life Sciences:
">We are a leading partner in the biotechnology industry, dedicated to delivering innovative solutions and services.
">Job Title: Operational Quality Assurance Specialist
">We are seeking an experienced Operational Quality Assurance Specialist to join our team in ensuring the highest standards of quality and operational efficiency.
">Key Responsibilities:
">- ">
- 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.">
Requirements:
">- ">
- 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.">
Compensation:
">The estimated salary for this role is $70,000 - $90,000 per year, depending on experience.
">Growth Opportunities:
">Gi Life Sciences offers a dynamic and supportive work environment with opportunities for growth and professional development.
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