QA Associate

Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements.

Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance.

Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists.

Participate in internal audits and assist with audit documentation and follow-ups.

Maintain and update records for compliance with ISO 13485 : 2016 and cGMP guidelines.

Assist in the preparation of technical files, labeling, and other product documentation as per EU MDR 2017 / 745.

Perform basic quality control tasks, including sample testing and maintaining lab instruments.

Support microbiological testing, media preparation, and water testing processes.

Help manage complaint investigations and contribute to implementing corrective and preventive actions.

Conduct training sessions on SOPs and quality procedures with supervision.

Stay informed of relevant regulatory changes and assist in updating documents accordingly.

Assist in compiling data for site master files, device master files, and regulatory reports.

Key Skills :

Associate

Qa

Pharma

Skills Required

Quality Assurance, Regulatory Compliance, Iso 13485, Cgmp, Document Review, Internal Audits