Quality Assurance Officer Injectable Manufacturing

il y a 4 semaines

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

We are looking for a **Quality Assurance Officer Injectable Manufacturing** who is **a teamplayer, stress resistant with a strong sense of ethics** to join us in our **Braine Site QA Operations** team, based in our **UCB Braine-l’Alleud Campus office** in **Walloon Brabant, Belgium**.

**About the role**

Together with appropriate management, you are responsible for the implementation and maintenance of an effective Quality Management System on the UCB Braine Site to assure that:

- Local technical operations related to the manufacturing of injectable pharmaceutical products (DP) complies with applicable national and/or international regulations and guidelines (GMP) & relevant UCB Quality Policies.
- Marketed injectable pharmaceutical Products are manufactured and supplied in accordance with UCB Product Quality Standards.
- To pro-actively help operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements

**Who you’ll work with**

You will work and have many stakeholders from within the Braine - Technical Operations department, especially the Injectable manufacturing department (including Filling and Visual Inspection activities) and you will be a part of the Braine Site QA Operations team.

**What you’ll do**
- You ensure the following relevant QA tasks are timely performed.
- You participate to product life cycle management including:

- Technology Transfer
- Process validation
- Equipment qualification
- Cleaning validation
- Stability studies
- Filing submission preparation and follow up of Regulatory Affairs commitments
- Authoring/follow-up of Product Quality Review/Continuous Process Verification
- You play an active role in the continuous improvement through:

- Review and/or approval of Change control, Failure investigation, Deviations, CAPA plans
- Shopfloor oversight: shopfloor/ tier meeting presence, housekeeping tours, Quality oversight (witnessing/assessing the aseptic techniques)
- Review and authorization of relevant Standard Operating Procedure
- Support to the preparation and execution of internal / external audits.
- You assist manager to achieve team objectives.
- You are the back up for other team QA Officers according to manager instructions

**Interested? For this role we’re looking for the following education, experience and skills**
- You hold a master’s degree in a relevant field (bioengineer, chemistry, pharmaceutical,) or equivalent by experience
- You have a minimum of 3 years’ experience in a regulated pharmaceutical environment in a similar position and/or experience related to Sterile Manufacturing
- You are following a fact-based decision-making process and show accountability and an attitude oriented towards delivery.
- You have a good knowledge of worldwide regulations pertaining to GMP (Good manufacturing practices).
- You have excellent interpersonal relationship skills.
- You have excellent oral and written communication skills in French and English.
- You have a well-developed sense of discretion and ethics.
- You are an excellent team player.
- You are stress resistant and able to make quality/compliance decisions in a business environment.
- You can independently identify, communicate and initiate problem solving processes.

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 for 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, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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