Develop and maintain quality management system requirements (Documentation, records, CAPA, MRB, Complaints)

Oversee quality testing (In coming inspection, IPC, FQC, EM, sterility) and R&D activities (Design Control).

Participate in internal and external audits.

Review approve and execute validation protocol and reports.

Perform batch release.

Review equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.

Monitors and controls the manufacturing environment. Ensure that production and packaging operations are performed according to approved procedures defined by the Company.

Handle Supplier quality management, including supplier qualification, quality agreements, supplier quality audit, maintenance of suppler records.

Participate in design activities

Participate in risk management activities

Reporting to QA \ RA Director

Requirements:

Experienced in pharmaceutical / medical device industry

Excellent organizational and planning skills, highly independent

Detail oriented, with an ability to multitask and prioritize in a fast- paced environment

Good problem- solving abilities, flexibility, team player with excellent interpersonal and presentation skills

Proficient use of standard MS Office applications

Fluent English (oral and written)