Manager - Quality Assurance - Pharma/Medical Devices (5-6 yrs)

Key Responsibilities:

- Ensure product quality and adherence to regulatory standards, including EU MDR 2017/745 and ISO 13485:2016.

- Assist in the preparation and maintenance of quality manuals, formats, and standard operating procedures (SOPs) in line with industry standards.

- Conduct internal audits and assist with the documentation, reporting, and follow-up of audit findings.

- Support the investigation of complaints and the implementation of corrective and preventive actions (CAPAs).

- Prepare and maintain technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets.

- Review and verify certificates of analysis (COAs), sterilization check sheets, calibration reports, and other related documents for compliance.

- Oversee microbiological testing, water testing, media preparation, and instrument operation in quality control processes.

- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements.

- Assist in the preparation and maintenance of site master files and device master files in accordance with regulatory guidelines, including Indian MDR.

- Participate in management review meetings and contribute to discussions on quality performance and regulatory compliance.

- Stay informed about changes to regulatory requirements, particularly in relation to EU MDR and ISO standards.

- Support the preparation of clinical evaluation reports, risk management analyses, and other regulatory documents.

- Conduct training sessions on quality-related topics, SOPs, and compliance requirements.

- Provide support in the maintenance and updating of quality control documentation, including testing records and procedural updates.

Qualifications:

- Bachelor's/master's degree in Life Sciences, Engineering, or a related field, with experience in medical device regulations (EU MDR, ISO 13485) and regulatory documentation.

- Knowledge of quality management systems, cGMP/GLP practices, and strong understanding of quality assurance processes, including complaint handling, CAPAs, and internal auditing.

- Excellent organizational, analytical, and problem-solving skills, with strong written and verbal communication abilities.

- Ability to work independently and collaboratively in a team environment; experience in microbiological testing and quality control procedures is a plus