Quality Assurance Specialist
vor 3 Wochen
We have an exciting opportunity for a Quality Assurance Specialist (m/f/d) in Switzerland.
Tasks- Manage activities supporting the global release of drug substances, products, and intermediates, including documentation approval, batch record review, investigations resolution, and change control assessment in collaboration with CMOs.
- Drive QA topics and serve as the main liaison for partner collaboration in development activities.
- Ensure compliance with Quality Assurance standards throughout the lifecycle of drug substances, products, and combination products.
- Supervise the GMP/GDP Development QA group within the Quality Assurance department.
- Conduct quality assessments during supplier/CMO evaluations.
- Lead issue resolution and QA review for CMC teams and Supply chain stakeholders.
- Initiate quality improvement initiatives internally or through CMOs.
- Manage investigations of complaints at CMO level and ensure timely completion.
- Implement relevant quality agreements and manage communication with QA peers from partner companies.
- Ensure a GMP/GDP compliant supply chain and GxP environment qualification status.
- Write, edit, assess, and approve relevant regulatory documents and support audits.
- Actively support the organization in regulatory requirements, technology, and training.
- Provide technical and compliance guidance on deviations, investigations, CAPAs, and change control.
- Review, evaluate, and approve deviations, CAPAs, and testing issues.
- Monitor the efficiency of the pharmaceutical quality system (PQS), establish relevant KPIs, and implement improvements as needed.
- Advanced University degree in Pharmacy, Chemistry, or a related technical/science field.
- Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control roles.
- Proven track record of managing Health Authorities inspections, conducting risk assessments, and effectively managing CAPAs.
- Comprehensive knowledge of pharmaceutical manufacturing processes, spanning both development and commercial stages, as well as expertise in the control of drug substances, drug products, and combination products.
- Demonstrated experience in leading cross-functional teams.
- Thorough understanding of (c)GMP/GDP and relevant international regulatory requirements, with the ability to accurately interpret and implement quality standards.
- Excellent verbal and written communication skills, with the ability to communicate clearly and professionally.
Thank you for considering this opportunity. I look forward to connecting with you.
NES Fircroft verfügt über mehr als 50 Jahre Erfahrung im Bereich des globalen Workforce-Management und der Rekrutierung von technischen Experten.
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