What we offer

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

Keyrus Life Science is looking for a senior QA Project Manager to join our consulting team for a client project based in Wavre. 

The purpose of the project is to support and give oversight to validation and manufacturing activities according to our client validation and
production procedures. 

Your challenges will be : 

• Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
• Review/Approve the validation documentation regarding the GMP requirements and the procedures (vaccines)
• Ensure that production practices are aligned with validation conclusion
• Attend all project meetings as QA validation representative
• Ensure timely escalation to Management of critical issues during validation
• Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
• Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
• To define the validation strategies through the change control process
• To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)

Profile

• Open for a temporary project of 4 months
• University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
• Tools (e.g. SAP, documentum) is an asset
• Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
• Knowledge of GMP / CFR / Eudralex …
• Knowledge of different regulations and standards related to validation activities
• Good interpersonal relationship skills
• Good oral and written communication skills in French & English
• Problem solving and achievement oriented
• To be a good team player in order to succeed in each validation project and routine activities
• To be able to use a risk-based approach for problem solving and prioritization of tasks
• Sense of urgency

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.