Quality Operational Readiness Engineer
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Our client, a pharmaceutical organization, is seeking an experienced professional to ensure quality readiness and compliance for the startup of a new production facility. The role coordinates quality-related activities during the facility qualification phase to ensure a seamless transition from construction to operational status. This position maintains full regulatory compliance and GMP standards throughout the commissioning process.
- Conduct quality risk assessments for new processes and procedures during the facility startup.
- Review qualification documentation including DQ, IQ, OQ, and PQ protocols and reports.
- Manage quality event investigations including root cause analysis and CAPA implementation.
- Assess change control requests for quality impact and ensure proper documentation and approval.
- Support regulatory submission activities and preparation for pre-approval inspections (PAI).
- Maintain quality management system documentation and ensure adherence to local and international GMP requirements.
- Provide real-time quality support to project teams through routine GEMBA walks.
- Bachelor's degree in Life Sciences, Engineering, or Quality Management.
- You have 3+ years of experience in pharmaceutical or biotech Quality Assurance.
- You bring a solid understanding of pharmaceutical manufacturing processes and technologies.
- You possess strong analytical and problem-solving abilities with experience in stakeholder management.
- You are fluent in English.
Nice to Haves
- Understanding of risk management and change management principles and methodologies.
- Experience working with external contractors in a project-driven environment.
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