Quality Operations Specialist
il y a 1 semaine
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 - Development and Validation.
The primary goal of this function is to be the QA referent for Early Phase and Validation products and to perform activities of the QA Operation department.
**The key tasks are (among others)**:
As a QA referent for products in clinical phases (GMP production) and validation, the major accountabilities include to:
- Be the quality point of contact for customers and participate in the project team meetings
- Manage customer requests, complaints, recalls and audits and organize the follow-up of findings
- Manage and approve change controls, CAPAs & deviations linked to the products and inform management in case of any major quality or regulatory issue
- Review and approve the documentation linked to the projects / products (MBR, analytical documentation, quality agreements, process validation, protocols and reports )
As a member of the QA operation team, the function also includes:
- Write, review and approve documentation related to quality activities
- Be the QA operations referent for PPL projects in clinical phases (GMP production) and validation, provide quality support to other departments and support the continuous quality improvement
- Work within the Quality and Regulatory team to maintain focused, effective progression in line with department and PPL objectives
**What we expect from you is**:
- **Master in Sciences **with minimum **5 year experience in QA in a GMP Environment**
- Experience in process validation
- Strong knowledge in GMP’s and ICH Q7 is a must
- 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.
**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.
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