kalpana patel

Pharma

Cipla • Full time

Jul 2021 - Present • 4 yrs 10 mos

I am a pharmaceutical professional with over 4.5 years of hands-on experience in Quality Assurance (QA), Production, IPQA, Validation, and QMS documentation within regulated manufacturing environments. Throughout my career, I have worked with reputed pharmaceutical organizations, contributing to high-quality production standards, regulatory compliance, and continuous process improvement. In my professional journey, I have been extensively involved in managing Quality Management System (QMS) documentation. My responsibilities included preparation, review, and control of standard operating procedures (SOPs), batch manufacturing records (BMR), batch packing records (BPR), and other GMP-related documents. I ensured that all documents were maintained in compliance with regulatory standards such as USFDA, EU-GMP, and MHRA. I was also responsible for issuing controlled copies and maintaining proper document lifecycle management, ensuring traceability and audit readiness at all times. A significant part of my role involved leading visual inspection activities for sterile injectable products. This required a high level of precision and attention to detail to identify defects such as particulate matter, cosmetic defects, or container closure integrity issues. I ensured that inspection processes were performed as per standard procedures and regulatory expectations, maintaining product quality and patient safety. I have also actively contributed to digitalization initiatives within pharmaceutical operations. I supported the transition from manual documentation systems to digital batch records and audit trails, improving data integrity and operational efficiency. My involvement in digital transformation projects helped enhance compliance with data integrity guidelines such as ALCOA+ principles, ensuring accurate, consistent, and reliable data management. Audit preparedness and compliance have been key aspects of my experience. I have supported both internal and external audi