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משרה בלעדית
קווליטסט
Location: Netanya
Job Type: Full Time
Qualitest is growing and we are looking for a Validation Lead to join our team in Netanya
Responsibilities:
* Develop and execute validation protocols for equipment, processes, systems, and facilities used in pharmaceutical manufacturing, ensuring compliance with regulatory requirements such as FDA, EMA, and ICH guidelines.
Design and implement validation strategies for new product introductions, process improvements, and technology transfers.
* Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and * Regulatory Affairs, to ensure alignment on validation activities and timelines.
* Review and approve validation documentation, including protocols, reports, deviations, and change controls, to ensure accuracy, completeness, and compliance with regulatory requirements.
Responsibilities:
* Develop and execute validation protocols for equipment, processes, systems, and facilities used in pharmaceutical manufacturing, ensuring compliance with regulatory requirements such as FDA, EMA, and ICH guidelines.
Design and implement validation strategies for new product introductions, process improvements, and technology transfers.
* Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and * Regulatory Affairs, to ensure alignment on validation activities and timelines.
* Review and approve validation documentation, including protocols, reports, deviations, and change controls, to ensure accuracy, completeness, and compliance with regulatory requirements.
Requirements:
* BA/BSc degree or equivalent in Science or Engineering is required, or a technical diploma with practical engineering experience.
* 3-5 years experience in the pharma industry
* Required knowledge and experience with equipment utilities validation, preferred knowledge and experience with water systems, validations.
Knowledge and experience with generating, revises and executes documentation for validation studies ensuring compliance with QA and cGMP systems.
* Performing DQs, Impact Assessments, Criticality Assessments.
* Knowledge and experience with generating and executing validation protocols Writing IQ, OQ and PQ protocols, executing validations per protocols, Writing IQ, OQ and PQ Reports. Performing and summarizing various annual testing.
Knowledge and experience with discrepancies, deviations and RC investigations writing required.
* BA/BSc degree or equivalent in Science or Engineering is required, or a technical diploma with practical engineering experience.
* 3-5 years experience in the pharma industry
* Required knowledge and experience with equipment utilities validation, preferred knowledge and experience with water systems, validations.
Knowledge and experience with generating, revises and executes documentation for validation studies ensuring compliance with QA and cGMP systems.
* Performing DQs, Impact Assessments, Criticality Assessments.
* Knowledge and experience with generating and executing validation protocols Writing IQ, OQ and PQ protocols, executing validations per protocols, Writing IQ, OQ and PQ Reports. Performing and summarizing various annual testing.
Knowledge and experience with discrepancies, deviations and RC investigations writing required.
This position is open to all candidates.
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