Pushkar Rana

Head of Quality @ Biofarma Group

About

Results-driven Quality professional with 15+ years of experience including 8+ years of people management in pharmaceutical quality control, quality assurance, compliance, and operational quality excellence. Proven expertise in GMP compliance, supplier qualification, QMS implementation, regulatory audits (FDA, EMA, MHRA, WHO, ISO), and driving continuous improvement. Adept at leading cross-functional teams to ensure product quality, mitigate risks, and maintain inspection readiness. Strong track record in resolving complex deviations, customer complaints, and fostering a culture of quality systems.

Country

China

City

Shanghai

Industry

Pharmaceuticals

Skill

Good Manufacturing Practice (GMP), Regulatory Audits and Inspections, , Quality Operations, People Management, Method Transfer, CMO management, Continuous Improvement, MHRA, Standard Operating Procedure (SOP), Product Sampling, Laboratory Quality Assurance, Food & Drug Law, Technology Transfer, Federal & State Regulatory Compliance, Good Manufacturing Practice (GMP), Supplier Evaluation, Quality System, Root Cause Analysis, Corrective and Preventive Action (CAPA), Quality Risk Management, Quality Control

Experience

Head of Quality

Biofarma Group

2018-11 - Present · 7 yrs 11 mos

Shanghai, China

Overall management and leadership of Quality, RA and supply chain and vendor qualification. Spearheaded quality operations of company with multiple products portfolios of Nutraceuticals, Specialty products, Herbal Extract, Amino acids etc. Developed and implemented robust CAPA processes, improving compliance and reducing repeat deviations by 50%. Led 20+ successful regulatory audits with zero critical & major observations; reduced audit findings by 50% through proactive gap assessments. Establish and directed supplier qualification program, Establish a site-wide Quality Culture/training program, Oversaw complaint handling system; Played a key role in cross-functional decision-making for product recalls, change controls, and deviation closures. Point of contact for Regulatory affairs

Assistant Quality Assurance Manager

Cipla

Customer-Focused Compliance: Directed QC operations for 15+ pharmaceutical and biotech CMO, ensuring alignment with diverse regulatory requirements (FDA, EMA, Health Canada, ANVISA). Maintained 100% on-time batch releases and zero product recalls over 5 years. Data Integrity and electronic control: Implemented electronic Quality Management Systems (eQMS), leading to a 25% increase in operational efficiency. Tech Transfer Success: Led QA oversight for 12+ tech transfers (oral solid dose, sterile injectables), achieving 20% faster validation timelines through proactive gap analysis and client-collaborative protocol design

Quality Assurance Manager

Gracure Pharmaceuticals Ltd.

Successfully led the site QA & QC teams for EU GMP audit. Collaborated with R&D team, design and implemented the R&D QA system to upgrade the GMP system in R&D department. Designed a risk-based audit program that improved supplier compliance by 25%. Managed batch record reviews and release processes for 100+ products of different pharmaceuticals dosages, maintaining 99% on-time in full delivery. Developed supplier qualification program, execute the supplier audit and managed corrective actions for critical supplier issues.