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, periodically review, revise, 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 and ensure implementation of standardized operating procedures.
Approve documents according to templates and required GMPs, ISO IMS (ISO 9001:2015, ISO 13485:2016), 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 and ISO13485:2016 training for relevant staff.
Analyze, monitor, and ensure that the organization's processes comply with international standards.
Requirements
5 years of experience in a similar position.
Experience in the pharmaceutical or medical equipment industry.
Working knowledge of relevant GMP, ISO 13485:2016 guidelines and regulations.
Familiar with risk management methods.
Bachelor's or Master's degree in Industrial Engineering or Industrial Management.