Analytical Methods Qualification
il y a 2 semaines
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.
- 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
- Customersoriented
- 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
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