PE Launch Excellence
Il y a 20 heures
Antwerp, Belgique
Akkodis
Temps plein
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🌟 Who we are
Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen.
In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.
Akkodis is part of the Adecco Group. You can find more information on our website : www.akkodis.com
🎯 Mission
You will support the introduction of new products. In this role, you will be responsible for managing all validation aspects associated with new product launches, ensuring processes meet GMP requirements and applicable regulations throughout the full product lifecycle. You will work closely with cross-functional stakeholders to coordinate process and system changes and to maintain robust documentation. This position requires strong technical expertise, precise project coordination, and the ability to perform risk assessments and quality investigations in a complex pharmaceutical environment.
đź“‹ Your responsibilities
• Validate and document processes for formulation, filling, inspection, shipping, and packaging in accordance with GMP and applicable regulatory requirements.
• Execute and thoroughly document urgent quality investigations, ensuring timely resolution and clear communication to relevant stakeholders.
• Draft detailed validation and investigation protocols, and coordinate sampling activities and required laboratory or in-process testing.
• Perform structured risk analyses for new product introductions and define appropriate mitigation measures to control identified risks.
• Coordinate and implement process and system changes associated with product introduction, ensuring alignment with operational, quality, and regulatory expectations.
• Manage project activities including planning, issue resolution, progress reporting, and stakeholder communication to ensure successful product launch milestones.
• Collaborate closely with Quality Assurance, laboratory, production, scheduling, Research & Development, and external partners to align validation activities with broader site objectives. 👤 What skills do you bring to the table?
• Master’s degree in Bioengineering, Pharmacy, Biochemistry, Biotechnology, or an equivalent scientific or technical discipline relevant to pharmaceutical manufacturing.
• Perfect Dutch language skills and good English language skills, both spoken and written, to manage documentation, communication, and regulatory interactions effectively.
• At least 2 years of experience working in a GMP environment, ideally within pharmaceutical or biotech production and validation activities.
• Demonstrated experience with validation projects and project coordination, including protocol development, execution oversight, and documentation management.
• Strong communication skills and a hands-on approach, with the ability to work independently while remaining organized, accurate, and quality-focused.
• Willingness and flexibility to work early, late, and weekend shifts during defined limited periods, depending on project and production needs.
• Ph.
D. degree is considered an advantage, particularly for complex technical problem-solving and advanced data analysis tasks.
• Experience with aseptic processes, including formulation, filling, and inspection, and strong technical writing skills for protocols and reports. 💡Our recruitment process Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist. Step 2: Interview (60 min) with a Business Manager. Step 3: Interview (60 min) with the client. 📩 Interested? Apply now or send an e-mail to bo.schoonjans@akkodis.com so we can get in touch
• Validate and document processes for formulation, filling, inspection, shipping, and packaging in accordance with GMP and applicable regulatory requirements.
• Execute and thoroughly document urgent quality investigations, ensuring timely resolution and clear communication to relevant stakeholders.
• Draft detailed validation and investigation protocols, and coordinate sampling activities and required laboratory or in-process testing.
• Perform structured risk analyses for new product introductions and define appropriate mitigation measures to control identified risks.
• Coordinate and implement process and system changes associated with product introduction, ensuring alignment with operational, quality, and regulatory expectations.
• Manage project activities including planning, issue resolution, progress reporting, and stakeholder communication to ensure successful product launch milestones.
• Collaborate closely with Quality Assurance, laboratory, production, scheduling, Research & Development, and external partners to align validation activities with broader site objectives. 👤 What skills do you bring to the table?
• Master’s degree in Bioengineering, Pharmacy, Biochemistry, Biotechnology, or an equivalent scientific or technical discipline relevant to pharmaceutical manufacturing.
• Perfect Dutch language skills and good English language skills, both spoken and written, to manage documentation, communication, and regulatory interactions effectively.
• At least 2 years of experience working in a GMP environment, ideally within pharmaceutical or biotech production and validation activities.
• Demonstrated experience with validation projects and project coordination, including protocol development, execution oversight, and documentation management.
• Strong communication skills and a hands-on approach, with the ability to work independently while remaining organized, accurate, and quality-focused.
• Willingness and flexibility to work early, late, and weekend shifts during defined limited periods, depending on project and production needs.
• Ph.
D. degree is considered an advantage, particularly for complex technical problem-solving and advanced data analysis tasks.
• Experience with aseptic processes, including formulation, filling, and inspection, and strong technical writing skills for protocols and reports. 💡Our recruitment process Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist. Step 2: Interview (60 min) with a Business Manager. Step 3: Interview (60 min) with the client. 📩 Interested? Apply now or send an e-mail to bo.schoonjans@akkodis.com so we can get in touch