DICEUS is a software development company specializing in delivering high-quality software solutions to clients worldwide. Our team is dedicated to creating innovative and reliable software products that meet the needs of our clients. We are currently seeking a Certified Software Quality Engineer (Middle) to join our team.
About the project
The client is significantly expanding its existing manufacturing facilities in Kalundborg, Denmark. Currently, the client is in the process of launching several large projects and is therefore seeking Certified Software Quality Engineers.
- Bachelor’s degree in a relevant field such as pharmaceutical sciences, pharmacy, chemistry, biology, engineering, or a related discipline.
- CSQE certification or other relevant certifications in quality management and software engineering.
- Previous experience in quality assurance, preferably within the pharmaceutical or life sciences industry.
- Familiarity with Good Manufacturing Practices (GMP) and regulatory compliance in the pharmaceutical sector.
- Understanding of quality management systems and standards applicable to the pharmaceutical industry (e.g., ISO 9001, cGMP).
- Knowledge of pharmaceutical regulations and guidelines, including those issued by regulatory authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).
- Experience with software validation and qualification processes for systems used in pharmaceutical manufacturing and quality control.
- Proficiency in risk management methodologies, especially as they relate to pharmaceutical quality systems.
- Strong skills in creating and maintaining documentation related to quality processes, including validation protocols, standard operating procedures (SOPs), and batch records.
- Experience in conducting or participating in internal and external quality audits.
- Understanding of change control processes within a pharmaceutical environment.
- Familiarity with implementing and managing CAPA processes to address quality issues and prevent their recurrence.
- Ability to perform root cause analysis to identify the underlying causes of quality issues.
- Knowledge of data integrity principles and practices, especially in the context of pharmaceutical manufacturing and quality systems.
- Strong analytical skills for evaluating data and solving quality-related problems.
- Effective communication skills to convey quality-related information to cross-functional teams and regulatory bodies.
- Commitment to continuous improvement in quality processes and systems.
- Understanding of CSV principles for validating computerized systems used in the pharmaceutical industry.
- Fluent in English (advanced)
- Knowledge of DCS 800XA, SattLine and MES systems as PAS-X or Syncade or systems alike.