Rama Joga V. Eranki

Sr. Director /Head of Quality & Compliance Drive enhanced compliance through continuous improvement initiatives, effective CAPA controls and quality metrics data for improved performance. Executive level GMP, GLP Management, strategy and continuous process improvement across multiple disciplines and cross functional teams with excellent people or team management and rich expertise in quality space. Experience working for start-up, mid-size and large organizations with overall experience of 27 years. Mentor, coach and develop talent within team members. Work within FDA regulated Healthcare industry in pharmaceutical manufacturing / quality / regulatory space. Implement continuous process improvement and culture. Experience in Track wise and Material Management systems and many trackers to ensure timely completion of activities. Areas of Expertise / Core strengths: FDA Inspections - Responses and closure of 483 Observations, Quality Operations & Management, Developing Quality metrics and Quality scorecard evaluation (on monthly basis), Internal and External Audits, FARs, Recalls, Deviation and CAPA Management, Effective Change control Management, Complaints handling, OOS reviews and dispositions, DEA related compliance management, Remediation of warning letters and improvement initiatives in quality metrics related to deviations/non- conformances, OOS investigations, Complaints, Internal audits and CAPA’s with timely updates to key stakeholders and FDA; RM, PM, FP and Stability testing within timelines, Method validation, Process validation, Equipment and facilities qualification, ANDA filing and regulatory supplements, annual report and post approval commitment with good knowledge, execution and interpretation of guidances, Annual product quality Reviews, developing and maintaining Quality agreements along with mentoring and coaching of my team members, conduct plant level training on certain topics like Data Integrity, Deviations/investigations (Non-conformances), CAPA (Corrective and preventive Actions), GDP and cGMP.

• Awards:
• Outstanding Leadership Award in recognition of my contributions to the field of healthcare at Health 2.0 Conference in Las Vegas, December 2022.
• Gold Medal awarded for being Topper in Master’s degree (M. Pharm)
• Director’s WOW (Work of World class) award for contributing to Zero Quality Defects in VapoRub exports at Procter & Gamble
• Several certificates and mementos awarded in recognition of commendable efforts at InvaGen & Cipla.

• Certified Quality Auditor, (ASQ)
• Certification course as Internal Quality Auditor by Business Excellence consulting (BEC), Puerto Rico
• Certification Training on Effective Deviation Investigations and CAPA Management by Business Excellence consulting (BEC), Puerto Rico