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.
We are GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA.
- Generation of Qualification Plans, Protocols and Reports
- Support of different Equipment and Systems owners by providing technical knowledge.
- Planning and execution of the qualification of equipment and systems together with the equipment owner, supporting contractors and vendors
- Carying-out risk analysis of equipment and systems independently
- Generation and updating of Standard Operating Procedures based on internal and external guidelines
- Participation in planning and execution of Computerized Systems Validation (CSV)
- Support in case of change control -, deviation- and CAPA processes
- Training of equipment and system related topics
- Experience in the pharmaceutical industry or health authority
- Knowledge of GMP and ICH guidelines
- 3 years of experience with Equipment Qualification
- Knowledge of Computerized System Validation
- Experience in change control -, deviation- and CAPA management
- Fluent in written and spoken German and English
- Proficient with MS Office applications
- You are a pro-active, positive thinking team player who is detail-oriented and you have good organizational and communication skills
- Experience in a GMP Quality Assurance department
- GLP experience
- Six Sigma and Lean experience
- SAP knowledge
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 €42.000 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.