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Quality Assurance Technician
hace 3 meses
**About us**
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 who will play a key role for our new Commercial Plant within the Quality Assurance department.
The job involves stablishing and maintaining commercial QA department with the assistance of Quality Assurance Lead.
**Responsibilities**
- Create, review, approve and maintain GMP documentation.
- Assist the technical teams on daily quality events with the support of all the Quality Assurance team.
- Support on project activities such as validations executions, creation of protocols, and write-ups of summary reports.
- Prepare and review: API, raw materials, bulk and finish product, release specifications.
- Review and approval of Pharma bulk and packaged batch records.
- Review and approve batch records for placing on the market or for regulatory purposes on different countries to be commercialized.
- Evaluation of daily problems encountered during the review of batch documentation and production necessities.
- Monitoring deviations reports raised on batches for approval.
- Review, maintain and approve all master batch records and their validation on SAP to manufacture according to the marketing authorization.
- Evaluate all requirements/requests made by the client (documentation request or information pertaining to product registration).
**About you**
- 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.
**Desired competencies**
- 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.
