Job Brief (Primary Responsibilities)
Assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP and ISO 13485 compliance support as necessary
Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP and ISO 13485 compliance support as necessary.
Primary Responsibilities :
Monitor and track quality system deliverables to completion including NC / CAPA actions, internal audit findings, supplier audits, and actions from management reviews and data reviews.
Assist with change control program management, maintain change control log, track activities, maintain documents, and prepare closures.
Track quality reports to completion.
Manage supplier documentation for production, release, and development activities.
Maintain and organize QA files for complaints, supplier management, and product release.
Publish monthly quality report and KPI trends
Revise SOPs / INSs, prepare flow charts and other quality documentation.
Identify compliance weaknesses and ensure the implementation of workable solutions.
Perform other related duties as required.
Qualifications / Requirements / Skills :
Associate degree or equivalent with a minimum of 2 years’ experience in a pharmaceutical or medical device industry.
Ability to exercise independent judgment.
Strong organizational skills.
Strong communication skills (encompasses verbal, written, interpersonal, listening).
High level of attention to detail and accuracy.
Flexible; ability to adapt to changing priorities.
Excellent time management skills (schedules, timelines, task prioritization).