Quality Operations Specialist

작업 내용

PolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of therapeutically active peptides. PolyPeptide SA, Belgium, with approximately 300 employees is part of the international PolyPeptide Group with companies in Sweden, India, USA, France and Belgium.

For the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist.

The key tasks are (among others):

• Manage, listen to and motivate the QA team, maintaining a sound work spirit and discipline
• Ensure that the required and continuing training of the team is carried out and adapted to needs.
• Manage the QA review of executed manufacturing batch records and QC report
• Manage the batch release preparation to ensure that release in performed on-time
• Provide day to day support and troubleshooting to production and QC operations in order to assure the respect of the current quality system and planning
• Perform internal audits as required
• Manage and approve change controls, CAPAs & deviations
• Inform management in case of any major quality or regulatory issue
• Develop, implement and manage documents related to Quality Operations activities in order to comply with the cGMP or other legislation and with PolyPeptide Quality System
• Monitor Quality indicators and help to gather and track relevant data.
• Work within the Quality team to maintain focused, effective progression in line with Polypeptide objectives
• Work with counterparts from other PPL sites to establish common best practices in quality related systems, policies and procedures

What we expect from you is:

• Master in Sciences with minimum 5 year experience in QA in a GMP Environment
• Fluency in French and English is mandatory (spoken and written English)
• Excellent command of Word, Excel and PowerPoint
• High organizational skills, good interpersonal skills, flexibility in tasks and schedules
• Sense of responsibility, enthusiasm, diplomacy and team spirit

Why you should apply

At PolyPeptide, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients and customers. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, excellence and trust. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

What we offer is :

• a full time contract
• an attractive salary
• extra-legal benefits and insurances
• a company car and fuel card
• a challenging position in an innovative and dynamic work environment with an open culture.