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Quality Assurance Professional
2 weeks ago
Job Title: Quality Assurance Associate
About the Role:
- We are seeking a highly motivated and organized Quality Assurance Associate to join our team.
Key Responsibilities:
- 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.
Requirements:
- Associate
- Qa
- Pharma
What We Offer:
The successful candidate will have the opportunity to work in a dynamic environment with a team of experienced professionals. They will receive comprehensive training and support to ensure their success in the role.
