MR Executive (Management Representative )

Key Requirements:

* B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech (Biotech / Biomedical / related discipline)

* 2–4 years of experience in Quality Assurance within pharma or medical device manufacturing

* ISO 13485 Lead / Internal Auditor certification preferred

Key ResponsibilitiesQuality Management System:

· Ensure that all processes required for the QMS are established, implemented, and effectively maintained.

· Oversee document control, CAPA, change control, deviation handling, and risk management systems.

· Ensure compliance with ISO 13485, ISO 9001, GMP, and other applicable regulatory standards.

· Facilitate internal and external audits, ensuring timely closure of observations and continuous compliance improvement.

Regulatory & Certification Compliance:

· Represent top management during audits and inspections conducted by ISO, CE, CDSCO, and other regulatory or certification bodies.

· Act as the key point of contact for regulatory authorities and certification agencies.

· Maintain up-to-date knowledge of relevant regulatory requirements and ensure timely implementation of any changes.

Performance & Reporting:

· Report to top management on the performance of the QMS, including key metrics, audit findings, and areas for improvement.

· Coordinate Management Review Meetings at defined intervals and track the effectiveness of resulting action plans.

· Support continuous improvement initiatives to enhance product quality, process efficiency, and regulatory compliance.

Training & Awareness:

· Promote awareness of customer, regulatory, and statutory requirements throughout the organization.

· Plan and conduct training sessions on QMS, GMP, and quality standards for cross-functional teams.

· Foster a culture of quality, compliance, and accountability across departments.

Key Skills & Competencies

· In-depth knowledge of ISO 13485, ISO 9001, and GMP requirements.

· Strong leadership, coordination, and communication skills.

· Proficiency in documentation, audit preparation, and compliance reporting.

· Analytical mindset with the ability to identify root causes and implement effective corrective actions.

· Skilled in liaising with external auditors, certification bodies, and regulatory agencies.

· Strong presentation and interpersonal abilities with a focus on continuous improvement.

Job Type: Full-time

Pay: ₹25,000.00 - ₹30,000.00 per month

Work Location: In person