Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). Prepare, review, and update SOPs, quality manuals, and quality policies. Manage change control, deviation, incident reporting, and risk management systems. Coordinate and support internal, external, and third-party audits , ensuring timely CAPA implementation and closure. Monitor and analyze quality metrics to drive continuous improvement initiatives. Provide training and awareness programs for QMS procedures and GMP compliance across teams. Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. Develop and maintain the Validation Master Plan (VMP) . Ensure periodic requalification and revalidation activities are performed according to schedules. Review and approve all validation-related documents, including protocols and reports. Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. Strong hands-on experience in QMS implementation and validation/qualification activities. In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). Strong communication, documentation, and audit-handling skills. Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. Location Indore Benefits: Competitive salary and performance-based incentives. Opportunity to work on global compliance and regulatory projects. Exposure to international audits and career advancement opportunities.
Job Title
Sr. Executive: QMS and Validation