QA Officer Drug Substance

Il y a 5 mois

Brainel'Alleud, Belgique UCB Temps plein

**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**
- 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)
- 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
- Review batch records from intermediates to drug substance
- Oversee batch disposition of chemical intermediates (DS manufacturing)
- Authorize technical transfers towards manufacturing (protocol and report)
- Authorize re-tests for chemical substances (DS manufacturing)
- Support BTO Management in developing and implementing technically robust and compliant Process and Equipment Support Systems to exploit and continuously improve operations.
- 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
- Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements concerning cGMP
- Promote quality and operational excellence, cultivating "Compliance Awareness," "Continuous Improvement Attitude," and "Accountability Culture" across the BTO and related supporting services
- Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
- Ensure communication of compliance status and issues to appropriate levels of the organization
- 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**
- A master's degree in chemistry/biochemistry or a degree in pharmacy/chemical or biochemical engineering
- 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
- Fluent in French (Braine working language) and English (for global interactions, including with customers and authorities)
- Experience with Quality Management System
- Demonstrated ability to balance multiple priorities, provide leadership and prioritization, and work with mínimal supervision
- Fact-based decision maker with a strong sense of accountability and a results-oriented attitude
- Excellent team player with outstanding interpersonal relationship and communication skills
- Capable of planning and directing the actions of a team of professionals and Quality Assurance personnel in multidisciplinary investigations and meetings
- Skilled in independently identifying problem situations, communicating effectively and initiating the problem-solving process
- 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

**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, o

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