Analytical Method Lifecycle Expert
il y a 3 semaines
We are looking for an Analytical Method Lifecycle Expert, for one of our clients based in Braine-l'Alleud/Wavre.
Don't hesitate to contact me : anne- - Life Sciences Wallonie.
This is a contract as a Consultant (employee or freelance): project until 31/12/2024.
responsabilités
As an Analytical Method Lifecycle Expert, here are the tasks you'll do:
Providing analytical expertise and day- to- day support to CMO's on methods and specifications (including implementation & changes of methods, troubleshooting) Providing support & analytical expertise for out of specification/expectation and complex analytical investigations at vendor site Reviewing analytical points in vendor deviations (analytical support & expertise for analytical items in Change Controls and assessment of analytical related actions) Ensuring coordination and oversight on analytical projects related to cGMP requirements at vendors. Coordinating of cross-laboratory studies, investigative testing and Technological transfer at vendors for analytical package Performing review of annual stability protocols and reports, results evaluation, trending, and documentation Ensuring new campaign preparation (including validation campaign) and coordination with the departments Working closely with Technical Operations teams to ensure that analytical support is provided in an effective and efficient wayqualifications As an Analytical Method Lifecycle Expert, here are the requirements: Minimum of 5 years working in the pharmaceutical industry in a GMP operational Quality Control /Development and/or Quality Assurance position. In-depth knowledge and understanding of analytical activities related to quality controls (deviations, method validations, out of specification management, ...). Excellent knowledge of analytical chemistry, analytical techniques and methods applied to active pharmaceutical ingredients and drug products (HPLC/GC/Dissolution/Karl Fisher, Pharmacopoeia and physical methods). Practical laboratory experience is a plus. Must possess excellent interpersonal, verbal, and written communication skills in English. Shows great ability to work in a team and demonstrates collaborative mindset. Delivering solutions Must have the ability to independently analyze data and information, to draw conclusions and make effective decisions. Has the ability to identify risks and propose corrective actions within areas of expertise.
qu'offrons-nous As an Analytical Method Lifecycle Expert, we offer an attractive salary with the following benefits: Hospitalisation insurance 7 euros meal voucher per day Reimbursement km or company car Monthly allowance (80 euros net per month) A 13th month Training A rate as a freelancer is also possible.
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