CSV Senior Specialist
CSV Senior Specialist
- Art der Anstellung: Vollzeit
- 53.500 € – 78.500 € (von XING geschätzt)
- Vor Ort
- Zu den Ersten gehören
CSV Senior Specialist
Über diesen Job
Your role
We are seeking a skilled CSV Senior Specialist to lead the validation of computerised systems across manufacturing, quality control, and warehouse operations. This critical role within the QA Validation team ensures compliance with regulatory standards and supports data integrity throughout the system lifecycle.
The chosen candidate will be responsible for:
- Lead CSV projects, ensuring systems meet regulatory and data integrity standards from validation through to operational use.
- Assess and manage changes to software and hardware, performing thorough risk analyses and ensuring validation lifecycle compliance.
- Develop, execute, and maintain CSV protocols and documentation in line with FDA, EU GMP, and corporate standards.
- Act as the CSV Subject Matter Expert during internal and external audits.
- Support equipment qualification activities and coordinate with vendors for related periodic qualifications.
- Contribute to quality investigations (e.g., deviations, CAPAs, complaints) in collaboration with the Quality Unit.
Your profile
· Graduate level qualification in a relevant field, preferably life sciences, combined with a strong IT background.
- a regulated pharmaceutical or life sciences environment.
Working at Siegfried
Who we are
What we do in Hal Far
Hal Far is our drug product manufacturing site for solid dosage forms. It offers innovative and generic drug products for the global market with a competitive cost structure at Swiss quality level.
Main activities
- GMP commercial manufacturing of solid oral pharmaceutical dosage forms
- Supply of tablets, film tablets, and hard capsules filled with powder or pellets, in bulk or blister packed
- cGMP high-potency suite
Features
- 1 –10 μg / m³ segregated cGMP production areas for high-potency
- 7 GMP suites: Dry & wet granulation, Tableting (up to 2 billion unit p.a.), Capsuling (up to 1 billion unit p.a.), Coating (up to 1 billion unit p.a.), Blistering (up to 100 million blisters p.a.)
Strategic importance
- CMO for innovative and generic drug products for the global market
- Competitive cost structure at Swiss quality level