Location: Wien / Austria
VelaLabs is an international, innovative contract laboratory offering analytical services for Biologics (ATMPs, Biopharmaceuticals, Originator products, Biosimilar Candidates / Biosimilars, Blood and blood components, Vaccines) Chemicals and Excipients from early stages of product development (non-clinical, clinical) until market release testing. The company is GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA.
- Creation, maintenance and continuous improvement of a GxP-compliant Quality Assurance system including e.g. document management, deviations, change control, CAPA, risk analysis, qualifications, validations
- Securing the validity of analytical performance through appropriate QA measures
- Monitoring the GxP conformity of all laboratory activities
- Supplier Management/Qualification
- Participation in internal and external audits
- Participation in Audit trail review
- Participation in risk management
- Training management
- Participation in Equipment Qualification/Computerized System Validation
- Experience in the pharmaceutical industry or health authority
- Experience in a GMP Quality Assurance department
- Knowledge of cGMP requirements
- Experience with Equipment Qualification, Validation
- Experience with Computerized System Validation
- Good, demonstrated verbal and written communication skills in English and German
- Proficient with MS Office applications
- Good organizational and communication skills and detail-oriented
- Positive thinking, team minded person with risked based mode of operation
- GLP experience
- Six Sigma and Lean experience
What you can expect
- Diverse creative environment and problem-solving atmosphere with a highly motivated team.
- Flexible working time
- Parking place in front of the company or public traffic ticket for Vienna
- You can expect an annual salary of €35.000 and guarantee overpayment for professional experience or above-average qualifications
We offer an interesting opportunity for a motivated positive thinking person.
Gender, age, ethnicity, sexual orientation and disability are irrelevant, we support diversity.