Analytical Methods Qualification

il y a 1 jour

Brussels, Belgique PlusOne Temps plein

For the creation a new business unit within the QC Department, they are looking for a (M/F):
**Analytical methods Qualification & Validation Manager**

In order to reinforce its structure and to answer to an increasing demand in terms of qualification and validation of analytical methods, a new role within the QC GMP has been created.

**The main responsibilities of the function include**:

- Manage, develop and coach a team of qualification & validation (Q&V) projects leaders & technicians (about 5 FTE)
- Develop the strategy of the teams in terms on qualification & validation to have fit for purpose analytical methods (implementation of the total error approach)
- Interact with the analytical development department (PTD) to strengthen the analytical Quality by Design (aQbD) approach
- Final review and approval of the GMP documentation (protocols, rapport) generated by the Q&V project leaders (PL)
- Support the Q&V project leaders in case of method troubleshooting and provide his/her support a large support to the PLs in direct contact with the customers/subcontractors.
- Ability to support and manage deviations linked to the Q&V activities
- Ability to discuss and challenge the strategy, results (included statistical analysis) and conclusions obtained during qualification/validation
- Accountable for regulatory / customers audits linked to Q&V.
- Bring a technical expertise (analytical/GMP/RA)
- Ensure that quality documents are properly delivered on time internally and to the customers
- Be on the lookout for opportunities for improvement and develop new efficient way of working
- Ensure adherence to the updated guidelines linked to Q&V.

**Requirements**:
**Your profile**
- Ph.D, MS, Pharmacist, biochemistry and/or molecular biology with at least 8 years of experience.
- Strong knowledge of GMP rules/data integrity/trouble shooting
- Demonstrated experience in leading teams
- Strong knowledge and expertise in development, validation of analytical methods applied to protein and plasmid products
- Customers-oriented
- Experience within a CDMO is a plus

**Your skills**
- Ability to engage and manage teams
- Strong technical skills: HPLC, UV, Elisa, etc.
- Very good knowledge of analytical processes from method development to release
- Very good knowledge of guidance’s for method development, qualification & validation
- Familiar with the analytical Quality by Design approach
- Good knowledge of statistical analysis applied for analytical methods
- Ability to communicate in English AND French (oral and written)
- Solutions oriented and continuous improvement mindset

**They offer**:

- A motivating job with direct impact on company's results
- An opportunity to work in a young, vibrant and growing team
- An attractive salary package

**Responsibilities**:

- Coaching & People Management
- Planning
- Expertise in Validation of Analytical Methods

**Competences**:

- Technical skills: Validation of Analytical Methods, HPLC, Elisa
- People Management
- English & French
- GMP

**Nice to Have**:

- CDMO experience

  • Analytical Chemistry Officer

    il y a 1 jour

    Brussels, Belgique Trasis Temps plein

    **Responsibilities** - You carry out analytical tests for the development, verification and/or validation of analytical QC methods. - You participate in the transfer of new QC analytical methods and in the optimization of existing QC methods. - You participate in the drafting of protocols, reports and procedures related to QC analytical methods. - You...

  • Analytical Chemistry Specialist

    il y a 1 jour

    Brussels, Belgique Trasis Temps plein

    As an Analytical Chemistry Specialist you will ensure that product control methods are adapted to meet the specifications previously defined in collaboration with the R&D and regulatory departments, while respecting compliance with good practices (GMP/ISO/....).Your responsibilities: - Define, develop and validate analytical methods and other control...

  • Junior Analytical Consultant

    il y a 4 jours

    Brussels, Belgique NielsenIQ Temps plein

    **Job Description**: **About this job** Global Client Delivery is a modern service team transforming the way we serve our clients with new and updated tools to help our teams get the job done quickly and easily. We are the team that partners with clients to fuse data, science, and the talents of our people to provide measurement and improvement for the...

  • Api Laboratory Technician

    il y a 2 semaines

    Brussels, Belgique Trasis Temps plein

    As an API Laboratory Technician, you participate in the development and robustness analysis of API manufacturing processes by performing organic synthesis and analytical chemistry experiments. You perform API production in a GMP environment. **Responsibilities**: - You carry out the experiments and quality controls necessary for your mission in compliance...

  • Data Analyst

    il y a 1 jour

    Brussels, Belgique Cleeven Temps plein

    **! Join a Dynamic and Exciting Team at Cleeven!** Are you prepared to join a dynamic, youthful company with an exceptional atmosphere? Are you eager to dive into meaningful work and advance your career? **WHO WE ARE** Cleeven is an international engineering consulting firm built on two fundamental principles: **OUR MISSION**: To enhance self-awareness and...

  • Senior Mechanical Design Engineer

    il y a 2 semaines

    Brussels, Belgique WhatJobs Temps plein

    Senior Mechanical Design Engineer - Geartrain system ENGIBEX Brussels, Brussels Region, Belgium Overview We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life. Job Description The mechanical Design Engineer will be part of the fast growing EV development team...

  • Senior Economist

    il y a 2 semaines

    Brussels, Belgique ICF Temps plein

    ICF helps its clients to consider the impacts of policy choices on the economy, environment and society. We offer research, analysis and programme management services to policymakers in the European Commission and national governments around Europe. We provide decision-makers with evidence on impacts, advice on how policies are working and analysis of the...

  • Standardization Coordinator

    il y a 1 jour

    Brussels, Belgique Eurofins Temps plein

    Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest...

  • Senior Business Analyst

    il y a 2 semaines

    Brussels, Belgique Sparagus Temps plein

    **Context**: Operate as business/functional analyst for the Onboarding Tribe **Description**: - Identify business needs - Act as interface between the project owner and project management - Bridge the business needs with IS - Define and analyze the business model using modelling techniques and methods - Manage the risk, quality and...

  • Business Analist

    il y a 2 semaines

    Brussels, Belgique Connect-ICT Temps plein

    **Operate as **business/functional analyst** for the Onboarding Tribe** - Function: - **Identify business needs**: - **Act as interface between the project owner and project management**: - **Bridge the business needs with IS**: - **Define and analyze the business model using modelling techniques and methods**: - **Manage the risk, quality and