QA Associate

4 weeks ago

Gandhinagar, India Mantras2success Consultants Full time

Job Description - 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

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