Job Description
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 and conduct third party audits of suppliers.
● Participate in management of employee training to ensure compliance with SOPs in accordance with relevant regulatory standards.
● Handle and ensure quality of documentation (control, retention, and archival), and support CGMP activities.
● Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
● Perform product release activities per CGMP requirements.
● Engage and collaborate with operations department to drive quality system and CGMP.
