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.
