Role & responsibilities
- You are responsible for Level I, II and Level III & Level IV documents, issue/review, and control.
- Establishment, Implementation, Maintenance & Improvement of Quality Manual and Management System Procedures.
- Coordination for external audits (Regulatory Audit & Client Audit etc.) and organizing internal audits of laboratory.
- Identification of deviations from the management system or from the procedures for performing laboratory activities.
- Initiation of actions to prevent or minimize such deviations.
- You have direct access to management so that you can frequently discuss on the performance of the management system and any need for improvement.
- Ensuring the effectiveness of laboratory activities.
- Participates in available and relevant proficiency testing (PT), inter laboratory comparison (ILC).
- Implementation of Quality Control and checks.
- Coordination with technical staff and external agency for calibration, AMC/CMC and maintenance of equipment.
- Organizing and giving Training / Conference / Seminar.
- Analyzing discrepancies in results, complaints, and feed backs.
- Conducting Internal Audit & Management review meetings.
- Responsible for maintaining requirements of accreditation agencies.
- Coordination for CIP (continual improvement plan).
- Closely coordinating with Hyderabad Lab and working as a deputy in absence of Quality Manager of site.
- Submit all regulatory application and reply to regulatory bodies.
- Ensure implementation of all regulatory module.
- Work with Sales and Technical team for Scope enhancement as per business requirement.
Relevant Work Experience - 5-6 Yrs working with EIC and APEDA approved laboratory