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QA Expert

Darman Yab Group

Karaj
Posted 37 minutes ago

Job Description

● Prepare and complete quality documentation, meet professional QA objectives provide reports on a regular basis, and have experience in self-inspections internal and external audits. ● Develop, periodic review, revision, and implement SOPs and other documents needed in different processes. ● Assist in the investigation process and define optimized process work. ● Follow priorities in order to implement corrective and preventive actions. ● Quality risk management. ● Apply CAPAs or change management. ● Participate in corporate meetings to support strategies, for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively. ● Apply principles of continuous improvement. ● Apply and ensure implementation of standardized operating procedures. ● Approve documents according to templates and required GMPs, ISO IMS, etc. ● Assess audit findings. ● Provide inspectors with clear and comprehensive files (external audits). ● Respond with proficiency to questions from inspectors (external and internal audits). ● Periodic GMP training for relevant staff. ● Analyze, monitor, and ensure that the organization's processes comply with international standards. ● Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.

Requirements

● Master's degree in Industrial Engineering. ● More than 3 years of relevant experience in the regulated pharmaceutical industry, specifically including quality assurance. ● Experience with GMP and ISO inspections. ● Understanding pharmaceutical policies and rules. ● Fluent in MS Office. ● Fluent in English. ● High teamwork spirit.