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5 years of experience in Pharmaceutical Industry associate with a GMP background * Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
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Operational experience in GMP in Quality, Manufacturing, or Quality Control would be an asset. * Experience in GMP audits and inspections
Knowledge of GMP regulations and best qualification practices
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc - Operational GMP or quality experience would be a distinct advantage
Assurer le respect strict des procédures établies et des normes de qualité telles que GMP et ISO 17025. * Vous maîtrisez les standards de qualité tels que GMP, ISO 17025, avec une connaissance approfondie des pharmacopées.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product. * A good knowledge of GLP/GMP rules is a plus.
Oversee the CPLO GMP activities and ensure all employees understand and follow all standard operating procedures. * Assist in ensuring inspection readiness, as well as participate in maintaining facility GMP compliance. * Assist management and in the writing of quality items such as Deviations, CAPA, Change Control, as well as writing of GMP documents relative to CPLO documentation to ensure compliance with all policies and procedures. * Excellent understanding in GMP related environment : at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality. * Proven and recognized expert in the field of GMP Compliance.
Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner * Maintain GMP compliance and inspection/audit readiness at all times. Operational GMP experience or clinical activities experience would be a distinct advantage.
Knowledge of Good Manufacturing Practices (GMP) in a laboratory setting.
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Snel solliciteren
Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GMP GLP.
Strong knowledge of Good Manufacturing Practices (GMP).
Experience: Preferably in CAPEX projects within a commercial GMP facility.
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Vous avez un réel intérêt pour le domaine pharmaceutique et connaissez les règles GMP.
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