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 Product Quality Engineer (Middle) to join our team.
Job Role overview
As a Product Quality Engineer, you will be an integral part of the Quality Team, responsible for ensuring the highest standards of quality and compliance in the pharmaceutical projects in Kalundborg. You will work closely with cross-functional teams and stakeholders to implement quality management systems and ensure adherence to regulatory requirements.
- Collaborate with the Quality Team in pharmaceutical projects in Kalundborg to drive quality initiatives.
- Contribute to the development and implementation of quality management systems and standards.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
- Conduct software validation and qualification processes for systems used in pharmaceutical manufacturing and quality control.
- Create and maintain documentation related to quality processes, including validation protocols, standard operating procedures (SOPs), and batch records.
- Participate in internal and external quality audits and address any non-conformances.
- Implement and manage Corrective and Preventive Actions (CAPA) processes to address quality issues and prevent their recurrence.
- Perform root cause analysis to identify the underlying causes of quality issues.
- Collaborate with cross-functional teams to communicate quality-related information effectively.
- Drive continuous improvement initiatives to enhance quality processes and systems.
- Ensure data integrity principles and practices are followed in pharmaceutical manufacturing and quality systems.
- 3 years of experience in quality assurance within the pharmaceutical 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 and EMA.
- 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 documentation skills, including validation protocols, 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.
- Knowledge of DCS 800XA, SattLine, and MES systems such as PAS-X or Syncade or similar systems.
- Ability to perform root cause analysis to identify the underlying causes of quality issues.
- Knowledge of data integrity principles and practices in 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 spoken English.
- Readiness to relocate to Denmark.
- CSQE certification or other relevant certifications in quality management and software engineering is an advantage.