- Collaboration with global and local quality assurance and end-users for continuous enhancement of data integrity and management concepts and best practices throughout the lifecycle.
- Working with cross-functional teams on system implementations, issue resolution, and process enhancements.
- Independently maintaining and enhancing the computer system validation and data integrity program.
- In-depth understanding of regulatory requirements and their interpretation by inspectors within the pharmaceutical or medical technology industries.
- Conducting risk analyses of validation documentation, systems, and practices, and communicating identified risks, including recommending and implementing corrective actions and improvements.
- Conducting regular system reviews with system owners.
- Developing and reviewing/updating policies, procedures, templates, and forms.
- Actively supporting inspections (e.g., by regulatory authorities).
- Researching new technologies, existing processes, and references to recognized standards and frameworks.
- Identifying potentials and implementing them in the continuous improvement process.
- Bachelor's degree, preferably in the field of natural sciences and/or technology
- Experience in the biotech, pharmaceutical, medical technology, or a similarly regulated industry
- Minimum of 3 years' experience in the development, testing, implementation, and validation of computer systems and their quality control
- Proven successful implementation of cGMP projects
- Experience with the risk-based approach to validating computer systems
- High attention to detail, particularly regarding data consistency in documentation
- Excellent German and English language skills to articulate complex technical matters accurately
-
CSV engineer
vor 2 Wochen
Optimus Life Sciences Hamburg, DeutschlandJob Title: Senior CSV Engineer · Employment Type: Contract / Freelance · Duration: 9+ Months · Location: Hamburg Area, Germany · Responsibilities: · Responsible for ensuring orderly workflow in regulated qualifications and validations of computerised systems · Actively i ...
-
Doctoral / Postdoctoral Position in Digital Twin
vor 6 Tagen
Helmholtz-Zentrum Hereon Geesthacht, DeutschlandBeginn der Ausschreibung Ende der Ausschreibung Institut bzw. Bereich- Institut für Küstensysteme - Analyse und Modellierung- Standort- Geesthacht- Bewerbermanagement- Frau Erika KrügerWe invite enthusiastic applicants to fill a PhD or PostDoc position in the area of Digital Twin ...
-
Data Engineers
vor 2 Wochen
Optimus Life Sciences Hamburg, DeutschlandJob Title: Senior CSV Engineer Employment Type: Contract / Freelance · Ensure compliance with Data Integrity standards · Coordinate qualification and validation measures and report on progress · Collect, review, and archive qualification documents and raw data · Bachelor's/Ma ...
CSV Engineer - Hamburg, Deutschland - Optimus Life Sciences
Beschreibung
Title: CSV Engineer
Location: Hamburg Area, Germany
Type: Contract / Freelance (6 months+)
Responsibilities:
Requirements:
I am expecting a high volume of applicants for this position so please get in touch as a priority if you wish to be considered.
Please send your updated CV to