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.
Requirements
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.
Updated: 1 month ago
Job ID: 11175727
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NES Global Deutschland GmbH / NES Fircroft
1001-5000 employees
Strategic Management Services
NES Fircroft verfügt über mehr als 50 Jahre Erfahrung im Bereich des globalen Workforce-Management und der Rekrutierung von technischen Experten.