Company Description
Lars Medicare Pvt. Ltd. is a leading manufacturer of high-quality IV Catheters and other single-use medical devices, catering to global markets across over 100 countries. With CE and ISO 13485 certified production facilities, Lars ensures the delivery of world-class, cost-effective, and reliable products. Established in 2007 as a 100% Export Oriented Unit, the company operates a state-of-the-art manufacturing facility in a pristine location on the outskirts of New Delhi, India. With branches in Dubai, UAE, and Toronto, Canada, Lars continually focuses on innovation, exceptional quality, and breakthrough engineering to meet the needs of its international clientele.
Job Title: General Manager QC / QA / RA
Company: Lars Medicare Pvt. Ltd.
Location: Sonipat, Haryana
Reporting To: Managing Director / Plant Head
Experience: 1218 years
Responsibilities
- Maintain absolute discipline and a culture of quality excellence within the production and laboratory areas.
- Establish, implement, and maintain a robust Quality Management System in accordance with ISO 13485, GMP, and global regulatory standards.
- Oversee laboratory operations ensuring rigorous testing of raw materials, in-process samples, and finished products under GLP guidelines.
- Act as the final authority for approving Certificates of Analysis (COA) for product release and Batch Manufacturing Records (BMR/BPR).
- Lead the Regulatory Affairs strategy, managing CDSCO compliance, product registrations, and international submissions including CE marking.
- Manage all validation activities including IQ, OQ, and PQ for equipment, sterilization, and manufacturing processes.
- Serve as the primary lead for regulatory inspections, certification audits, and customer audits, ensuring timely closure of all observations.
- Drive the CAPA, deviation handling, and change control systems to proactively mitigate quality risks.
- Oversee customer complaint investigations and product vigilance, implementing root-cause analysis and corrective actions.
- Ensure 100% traceability of raw materials, production batches, and finished goods through meticulous documentation.
- Provide strategic leadership and technical training to the QC, QA, and RA teams to enhance skill development and performance.
- Monitor laboratory equipment calibration, validation, and maintenance schedules to prevent operational downtime.
- Enforce strict health and safety norms and cleanroom hygiene protocols across all quality and production departments.
Requirements
- M.Pharm / B.Pharm / M.Sc in Microbiology, Biotechnology, or Chemistry.
- Extensive leadership experience in Quality Control, Quality Assurance, and Regulatory Affairs within the medical device or pharmaceutical industry.
- In-depth knowledge of ISO 13485, MD Rules 2017 (CDSCO), and international regulatory requirements.
- Proven track record of managing successful audits from international notified bodies and regulatory authorities.
- Strong expertise in validation protocols, risk management, and cleanroom manufacturing processes.
- Demonstrated ability to lead large technical teams and drive cross-departmental compliance.
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