Make your mark for patients
To strengthen our QA Operations department, we are looking for a skilled professional to fill the position of: QA Officer Drug Substance – Braine l’Alleud, Belgium
About the role
This role entails collaborating with management to oversee the implementation and maintenance of a robust Quality Management System at the UCB Braine Site. You'll be responsible for ensuring all technical operations related to pharmaceutical manufacturing (DS) adhere to national and international regulations (GMP) and UCB Quality Policies. Moreover, you'll guarantee that our pharmaceutical products meet UCB Product Quality Standards throughout manufacturing and supply processes.
Take an active role in supporting operations by identifying, developing, and implementing quality and operational excellence enhancements in line with business needs, technical advancements and regulatory standards. Lead initiatives for continuous improvement, focusing on minimizing risks, elevating KPIs and enhancing product quality.
What you will do
1. Assure that intermediates and active pharmaceutical products are produced and released in accordance with UCB Quality Standards and applicable national/international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
2. Follow up on product-related change control, failure investigation, deviations (planned and unplanned), qualification of dedicated equipment (protocols and reports), cleaning validation of dedicated equipment, process validation (protocols and reports), stabilities (protocols and reports), CAPA and action plans
3. Review batch records from intermediates to drug substance
4. Oversee batch disposition of chemical intermediates (DS manufacturing)
5. Authorize technical transfers towards manufacturing (protocol and report)
6. Authorize re-tests for chemical substances (DS manufacturing)
7. Support BTO Management in developing and implementing technically robust and compliant Process and Equipment Support Systems to exploit and continuously improve operations.
8. Drive the identification of improvement opportunities and the development of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the Braine site
9. Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements concerning cGMP
10. Promote quality and operational excellence, cultivating "Compliance Awareness," "Continuous Improvement Attitude," and "Accountability Culture" across the BTO and related supporting services
11. Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
12. Ensure communication of compliance status and issues to appropriate levels of the organization
13. Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Interested? For this position you’ll need the following education, experience and skills
14. A master's degree in chemistry/biochemistry or a degree in pharmacy/chemical or biochemical engineering
15. Minimum of 3 years in a regulated pharmaceutical environment or other life science or health related field, including experience in Quality Assurance or Quality Control
16. Fluent in French (Braine working language) and English (for global interactions, including with customers and authorities)
17. Experience with Quality Management System
18. Demonstrated ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision
19. Fact-based decision maker with a strong sense of accountability and a results-oriented attitude
20. Excellent team player with outstanding interpersonal relationship and communication skills
21. Capable of planning and directing the actions of a team of professionals and Quality Assurance personnel in multidisciplinary investigations and meetings
22. Skilled in independently identifying problem situations, communicating effectively and initiating the problem-solving process
23. Resilient under stress
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!