We are leading pharmaceutical GMP audit consulting firm in India. The company is involved in providing auditing services, Director of company is Six Sigma MasterBlack Belt Certified Professional with over 22 years of experience in executing projects, devising quality management strategies, developing, implementing, managing, auditing and maintaining G×P quality systems to support commercial and early & late stage product development activities.
A keen planner, strategist & implementer with skills in setting up as well as ensuring smooth functioning of overall operations & enhancing operational efficiency by making use of leading edge technologies including business reviews across Pharmaceutical industry. Gained rich expertise in CGMP documentation & quality assurance, implementation & qualification of process. Expertise in analysing in-process & finished product specifications for regulatory filings and CTD’S & batch manufacturing records. Championed the incorporation of quality improvements starting from facility design, facility qualification submission batches, regulatory filings and pre and post approval inspections from strictly regulated countries.
Impeccable record of building high performance teams, implementing continuous improvement programs and partnering with multiple stakeholders. Provided thought leadership management in defining, implementing, ensuring, measuring & continuous improvement of reduction of OOS and batch failure process. Process along with quality standards, frameworks, practices and measurements. Acted as SPOC for quality related issuesat internal & external levels; ensured compliance at manufacturing site of Indian Pharmaceutical and Lead for Audit Remediation. Credit of initiating efforts & reviewing the entire water system; establishing systematic approach for PW & WFI, qualification approach, PM & sanitization, passivation, systematic drawings & water trends. Faced regulatory audits across the globe at Giant Indian Pharma such as USFDA, MHRA, TGA, MCC, UNICEF, Brazil, WHO, Uganda (National Drug Authority), PEPFAR, Ministry of Health Ivory Costa. Fore fronted several customer audits like Watson Pharma USA, Teva/Ivax USA, Sandoz, USA, Chanelle Pharma, UK, Fannin (Neolab) UK, S&D Pharma UK and Alfred Tiefenbacher, Germany .
Acted as Internal Auditor for self-inspections in formulation (Sterile, Non-sterile) and API Facility located in India, worked with LCS Consultants for OOS / OOT Investigation for 15 days, participated in lab simplification and paper less laboratory.
Quality
100 % quality to the customer services and customer focus
Ethics
Honesty, Confidentiality and integrity is our Ethics
Vision
To deliver the services with passion and consistency up to customer’s satisfaction level.
Our Customers
Major quantum from pharmaceutical , chemical and FMCG industry , Automobiles.
Engineering , medicals , Technology , Biotech , Banking and service industry , ONGC , corporate customers.
Retail customers – Anyone in the quality engineering and management field. Operations managers. · Industrial/mechanical/manufacturing engineers/managers. Corporate leaders , senior leadership members.
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