Sr. Executive QMS and Validation

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.,