کارشناس تضمین کیفیت

Job Description

• Assist in establishing, maintaining, overseeing, and enforcing all quality assurance standards and programs to assure compliance in accordance with ISO 13485 and GMP.
• Initiate, revise, and review controlled GMP documentation including procedures and reports.
• Interact with management, peers, and partners to assess and improve the adequacy of the QMS processes and procedures.
• Support Employee Quality Training - design and delivery for company-wide compliance. Promote a culture of quality.
• Participate in nonconformance and CAPA identification, investigation, and resolution.
• Maintain quality assurance and design control documentation with relevant stakeholders.
• Participate in internal and external audits for Happily and conduct third-party audits of suppliers.
• Participate in the management of employee training to ensure compliance with SOPs in accordance with relevant regulatory standards.
• Handle and ensure the quality of documentation (control, retention, and archival) to support CGMP activities.
• Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
• Perform product release activities per CGMP requirements.
• Engage and collaborate with the operations department to drive quality system and CGMP requirements.