Switzerland Job Openings
ALTOGEN AG
Data Integrity Specialist (M/F/X)
Lausanne
FULL TIME
September 20, 2024
With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
Learn more about us on our webpage : www.altogen.ch
To strengthen our team in Lausanne (Switzerland), we are looking for a Data Integrity Specialist (m/f/x).
Main Responsibilities:
- Develop and implement data integrity protocols, ensuring compliance with industry standards and regulatory requirements.
- Assess and analyze systems (e.g., MES, LIMS, SCADA) for potential data integrity risks and propose mitigation strategies.
- Conduct data integrity audits, identifying gaps, and driving CAPA processes to resolve issues.
- Ensure that all electronic and paper-based records comply with ALCOA+ principles.
- Collaborate with IT, Quality, and Manufacturing teams to develop robust procedures for data management and protection.
- Support the validation of computer systems, including system controls, user access, and audit trails to ensure data security.
- Stay current on FDA, EMA, and global regulatory trends and best practices related to data integrity.
- Bachelor's or Master’s degree in computer science, engineering, life sciences, or a related field.
- 3-5 years of experience in data integrity within the pharmaceutical industry, with a strong understanding of GMP and ALCOA+ principles.
- Familiarity with regulated systems such as LIMS, SCADA, MES, and ERP systems.
- Hands-on experience with data integrity audits, risk assessments, and validation of computer systems.
- Knowledge of global data integrity regulations, including 21 CFR Part 11 and EU Annex 11.
- Strong analytical and problem-solving skills with attention to detail.
- Excellent communication and teamwork skills, with the ability to work across multiple functions.
- Fluency in English and French are required,
WHAT WE OFFER :
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirit and an integration within the "Tribe"
Schedule:
- Monday to Friday
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