Provide support for QA activities related to Quality systems, Operations, Validation and/or CSV within the pharmaceutical industry.
Primary Tasks & Responsibilities:
- Ensure support is provided to develop process documents that are in alignment with regulatory expectations and internal global policies and standards
- Ensure state-of-the-art and best industry practices are reflected
- Manage QA activities related to one or more Quality Systems
- Support the development of transversal GxP Process:
– SOPs
– Deviation/CAPA Management
– Training Management
– Archive Management
– Documentation Management
– Changement Management
– Management review
- Manage relationship with operations
- Identify potential quality and compliance risks and help to manage these risks through the existing quality systems
Experience, Knowledge & Soft Skills Requirements:
- Previous experience in QA in a bio/pharmaceutical industry
- Experience in GxP (Aseptic, validation, cGxP, GMP)
Soft skills:
- Hands-on approach (able to work on the shop floor with a coaching and mentoring style to impact individual experiences)
- Strong communication skills (able to communicate with different levels)
- Influencing skills
- Flexible mindset
- Knowledge sharing
- High negotiation skills
- Achievement oriented
Education, Methodology & Certification Requirements:
- Master in Sciences linked to Pharma/Biotechnology (Engineering, Automation, Bioengineering, Chemistry…) or equivalent by experience.
- GxP (Aseptic, Validation, cGXP, GMP)
- Knowledge of norms like CFR21Part11, Eudralex, Gamp5…
- ICT Skills (software, operating systems, hardware, etc.)
Language Proficiency Requirements:
- French Fluent (Both Written and Spoken)
- English Good Knowledge