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Let's push the boundaries together and make the most of your talents!

Head of Chemical API Manufacturing QA

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  64791

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

To strengthen our Braine Site Operations Department, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of: Head of Chemical API Manufacturing QA.

 

Do you see yourself as a pragmatic person who maintains ethical ways? UCB believes you to be a ‘pragmathical’ person. This very special blend of talent means you are using your heart and your mind to help patients live a fuller life.

 

As a UCB 'pragmathical' person and Head of Chemical API Manufacturing QA you like to work in an environment where you can:

 

Implement and maintain an effective Quality Management System on UCB Braine Site.

Pro-actively help operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements.

Cascade and translate Site QA Operations strategy in objectives for Chemical QA manufacturing team, lead and develop the Chemical QA Manufacturing team accordingly.

 

As a UCB 'pragmathical' person and Head of Chemical API Manufacturing QA you will contribute by:

 

Enforcing compliance of QA team operations with relevant company quality systems and GMP.

Approving / authorizing general procedures and Plant/Site Master Files related to relevant scope.

Authorising the specifications of the chemical materials, manufactured/outsourced intermediates and manufactured API by delegation of the Site Qualified Person.

Organizing / managing relationship with internal customers in order to provide timely follow-up of product related deviations, change controls, investigations, complaints, release.

Managing a team of QA professional in view of recognizing / developing talent and be able to support operation at all time.

Actively contributing to simplification and streamlining of processes in order to remove unwanted roadblocks and support continuous quality improvement.

Providing support to QA S&CI during inspections by relevant authorities and to provide answers to audit report and relevant action plan.

Providing technical expertise, interpretation and direction to the company management concerning Quality Assurance, regulatory CMC files and relevant company policies.

Handling QA aspects with external customers.

Interacting with supply chain to timely provide products to the markets and to reduce inventory levels.

Escalading to senior management any critical quality issues and propose possible solution.

 

Interested? For this position you’ll need the following education, experience and skills:

 

Minimum 5 years of experience in QA (experience in production would be an asset)

In-depth knowledge of worldwide cGMP regulations.

Knowledge of GMP Quality System requirements.

Ability to manage effectively and strategically plan to meet company objectives both short and long term.

Excellent oral and written communication skills in French & English.

Excellent interpersonal relationship skills.

Team player attitude and customer oriented.

Stress resistant; able to make quality/compliance decisions in a business environment.

Fact based decision making process, accountability and delivering attitude.

Ability to plan and direct the actions of a group of professional quality assurance personnel.

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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