Quality Assurance Technician
Viralgen is a CDMO born as a joint venture between Askbio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.
We are excited for our next QA Technician to join the Viralgen team!
About the role
We are seeking a QA Technician within the Quality Assurance department.
• Create, review, approve and maintain GMP documentation.
• Assist the technical teams on daily quality events with the support of all the Quality Assurance team.
• Review and approve manufacturing batch records.
• Evaluation of daily problems encountered during the review of batch documentation and production necessities.
• Monitoring deviations reports raised on batches for approval.
• Management of complaints, quality events and change control.
• Evaluate all requirements/requests made by the client (documentation request or information pertaining to product registration).
• Pharmacist, Chemical Engineer, Chemist, Biologist, or similar University Degree.
• Quality Assurance expertise and extensive knowledge on revision of GMP documentation.
Knowledge on electronic systems such as LIMS, Trackwise and SAP will be an asset.
• Biologics experience and sterile process is desirable.
• Familiar with GMP environment.
• Solid experience of 2-3 years within the sector with similar responsibilities. Desirable EMA or FDA.
• Fluent in English (writing and reading) and in Spanish, is highly desired.
• Ability to multi-task and meet deadlines in a fast-paced environment.
• Demonstrated ability to work both independently and in a team environment.
• Demonstrated ability to work well under pressure and meet tight deadlines.
• Demonstrated passion for producing high-quality work.
• Proactive management and positive attitude to change and challenges.
• Communication skills and self-management.
• Indefinite contract.
• Opportunities for professional development.HHRR DEPARTMENT
• Flexible schedule.
• Accompaniment in the learning and development process.
• Good working and international environment.
• Company activities.
• Social benefits.
Do you want to know more about how we can help you?