Beschreibung
Sector: Pharmaceutical / Medical Devices
Experience: Minimum 5 years in a similar position
For one of our prestigious clients in medical devices, we are looking for an Analytical QC Validation Engineer available ASAP.
Main missions
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Develop and optimise analytical methods intended for the control of products and processes in laboratory and industrial environments.
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Design, execute and document analytical method validations in accordance with regulatory requirements and current standards (ICH, GMP, applicable pharmacopoeias).
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Define and implement IPC (In Process Control) checks in production, to ensure process control and robustness of controls in an industrial environment.
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Build and use design of experiments (DoE) to evaluate critical parameters, optimise analytical performance and secure implementation in production.
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Write associated technical and quality documentation: validation protocols, reports, standard operating procedures (SOP), QC instructions and production documentation.
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Ensure the field interface between Laboratory, Quality and Production teams to support the transfer, implementation and continuous improvement of analytical methods.
Desired profile (optional if you want to add it):
- Engineer or Master’s degree in Chemistry / Analytics / Pharmaceutical
- Proven experience in development and validation of analytical methods
- Knowledge of GMP / QC / Production environments
- Mastery of statistical tools and design of experiments (DoE)
- Ability to work in a field and cross-functional role
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