Project Quality Engineer- Pharma industry
Posted 14 days ago · 0 applicants
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The role in plain words
- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or a related discipline
- Previous experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, vaccine, or medical device environment
- Solid understanding of GMP principles, quality systems, qualification, validation, and quality risk management
- Strong written and verbal communication skills
- Good command of English
- Experience supporting facility startup projects, equipment implementation, technology transfer, or manufacturing expansion projects
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Who this suits
Full job description
Original listing · kept for referenceQA Project Specialist
Location: Beit Shemesh, Israel
Phibro Animal Health Corporation is a global leader in animal health and nutrition, dedicated to helping veterinarians, farmers, and animal producers maintain healthy and productive animals worldwide.
As part of our continued growth strategy, Phibro is establishing an additional manufacturing facility in Beit Shemesh. We are seeking a QA Project Specialist to join this exciting initiative and play a key role in building the quality infrastructure that will support the facility from project execution through operational readiness and regulatory compliance.
This position offers a unique opportunity to participate in the establishment of a new GMP-regulated manufacturing site and work closely with multidisciplinary teams including Engineering, Validation, Operations, Regulatory Affairs, and Global Quality.
Key Responsibilities
• Represent Quality Assurance throughout the planning, implementation, qualification, and validation phases of the facility project.
• Ensure compliance with GMP requirements during the design, installation, and commissioning of manufacturing equipment, utilities, systems, and processes.
• Review and approve qualification and validation protocols, reports, procedures, risk assessments, and project documentation.
• Support the development and implementation of Quality Management System (QMS) processes and procedures for the new facility.
• Participate in Change Control, CAPA, Deviations, investigations, and Quality Risk Management activities.
• Collaborate with cross-functional project teams to identify quality risks and implement effective mitigation strategies.
• Support inspection readiness activities and contribute to regulatory compliance throughout the project lifecycle.
• Work closely with global and local stakeholders to ensure quality standards are successfully integrated into all project phases.
• Assist in the preparation of the facility for future internal and external audits and regulatory inspections.
Qualifications
• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or a related discipline.
• Previous experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, vaccine, or medical device environment.
• Solid understanding of GMP principles, quality systems, qualification, validation, and quality risk management.
• Experience supporting facility startup projects, equipment implementation, technology transfer, or manufacturing expansion projects is highly desirable.
• Strong written and verbal communication skills.
• Ability to work effectively in a dynamic, project-oriented environment and collaborate across multiple functions.
• Good command of English.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or a related discipline, Previous experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, vaccine, or medical device environment, Solid understanding of GMP principles, quality systems, qualification, validation, and quality risk management, Strong written and verbal communication skills, Good command of English