- Be involved in the successful execution of projects (Process Equipment) from A to Z and work closely with internal stakeholders and suppliers
- Be responsible for the requalification organisation and execution for all equipment and systems within scope
- Schedule, organise, coordinate, and follow up the commissioning/SAT and (re)qualification activities within the project team
- Ensure timely delivery and release of equipment and systems within schedule and budget, communicating the warnings and deviations to the management team
- Ensure correct and state of the art Qualification/Validation approaches, as established in the Validation (Master) Plan and procedures
- Be accountable for all cGMP decisions taken during the (re)qualification activities and this in consultation with the client's stakeholders
- Review and ensure oversight of the (re)qualification (IQ, OQ, PQ) activities and deliverables within the project team
- Ensure a transparent, fluent, and effective communication with all internal stakeholders as well as with external partners
- Be able to advice the various actors in case of issues or deviations
- Be able to manage the project respecting the established commissioning / qualification timelines and coordinate all actors (Contractors, Suppliers, Engineering, Users) to align them with the project planning
- Quickly understand the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
- Be able to multitask and know how to set priorities
- You hold a university degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline
- You have excellent communication skills in English + French or Dutch (written and spoken)
- You have a significant experience in pharmaceutical production environment, process validation, equipment validation and in developing projects in a production environment
- You are an expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA requirements & risk management tools
- You have Experience with engineering documentation (P&ID, functional specifications, ...) and qualification documents
- You have understanding of good practices in biopharmaceuticals
- You have knowledge in qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), and Biotech process equipment
- You build up the necessary technical knowledge and bring innovative ideas to keep improving
- You have the ability to work under pressure due to the requested flexibility and reactivity of the activities
- You use a risk-based approach for problem solving and prioritization of tasks
- You blow a quality and compliance mindset through the validation activities
- You have a hands-on mentality and eagerness to perform tests
- You have Strong communication, organizational and influencing skills to work transversely
- You are good team player and team coach versed in different disciplines to succeed in the validation project
- You work independently with minimal supervision and schedule tasks in time so the project can be delivered on time
- You are resourceful with a CAN DO mentality who can think proactively
- A challenging position with growing perspectives
- Full time contract (40hr/wk) employee or freelance and long-term collaboration
- Location: in Wallonia (Belgium), depending on your mobility and the clients' locations
- Ideal start date: very asap
- Employee: A competitive salary + 12 RTT
- Employee other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
- Freelance: a long-term collaboration and evolving perspectives
- A challenging job in a dynamic and knowledge-sharing network company
- The freedom to develop yourself in line with your ambition
- A great autonomy in your role, an excellent working atmosphere within a great team of experts in their domain
- Would you like to work for a small company with a top-level service?
- We are looking forward to meeting you soon.
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Life Sciences Qualification Coordinator - Wavre, België - 3HR
4 dagen geleden
Beschrijving
The scope
Our client is a Belgian Engineering office active in Life Science Industries (Pharmaceutical and Biotechnology), with expertise in Qualification & Validation.
With 25 employees/freelances and offices in Belgium, the company is now looking for a Life Sciences Qualification Coordinator for new projects within different Belgian pharmaceutical industries in Wallonia.
Do you like working in a small business with a family ambiance?
Are you ready to contribute to their continued growth?
Do you have a quality and entrepreneurial mindset and are you passionate about working in Life Science industries?
We love meeting smart and forward-thinking talents, so don't hold back
Your next challenge and responsibilities
As one of their Qualification Coordinator, you will
You could be their ideal colleague if
Only Europe-based and short-listed candidates will be invited for an interview, thanks for your understanding
Do you have a quality and entrepreneurial mindset and are you passionate about working in Life Science industries?
We offer you
Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues who have a professional attitude and attach considerable importance to teamwork; we stand for
Your application
We are looking for motivated and passionate individuals who love to build things and solve problems.
If this is you, please apply here.
Address your application to Mrs. Gwendoline de Robiano, CV, and a short motivation text, with reference « Permanent/Freelance* Qualification Coordinator »
Interested candidates need to have, at the time of application, the legal right to work in Belgium. We regret that we are not able to apply for work-permits on their behalf. Only Europe-based and shortlisted candidates will be invited for an interview, thanks for your understanding.
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