HARIPRIYA PONUGUPATI

• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
• Resolved problems, improved operations and provided exceptional service.
• Demonstrated creativity and resourcefulness through the development of innovative solutions.
• Drive Cost Improvement Projects (CIPs), Quality improvement programs.
• Support site quality strategic plan, annual goals, CAPEX, BP, JU, NU and all business and financial cycle related activities within the site.
• Approval of batch disposition decisions.
• Manage overall Quality Operations in compliance with regulation and J&J quality polices.

• Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
• Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
• Planned and budgeted accurately to provide business with resources needed to operate smoothly.
• Accomplished multiple tasks within established timeframes.
• Ensuring all laboratory activities are conducted in accordance with government regulations, safety requirements, Enterprise, Sector and Company policies.
• Ensuring cGMP compliance in all aspects of the laboratory functions.
• Oversight of Laboratory Instrument Lifecycle and Laboratory Software Lifecycle systems & Quality Systems.
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• Assisted with day-to-day operations, working efficiently and productively with all team members.
• Exercised leadership capabilities by successfully motivating and inspiring others.
• Ensure and monitor all the quality control activities in compliance with cGMP, GLP, safety requirement and in line with Sanofi standards.
• Maintain the Score card (+QDCI) to track quality KPI for the team.
• Approved (QMS) Quality Management system like change controls, incidents and Corrective and Preventive Action related to the regulatory and their critical compliance.
• Development of people, leadership, multi skill and succession planning at all levels.
• Participated in “Equipment qualification optimization” program is leading by Global Quality Control Excellence team.
• Approval of quality control related records & reports.

· External Manufacturing (CMO) Quality Assurance – Injectables, OSDs, Topicals, Cosmetics

· Ensure handling, manufacturing and distribution of pharmaceutical products follow the DRL Quality Manual.

· Acted as Single Point of Contact for all quality related activities at the External Supplier.

· Ensure that a valid QA agreement defined in line with the requirements of the Dr. Reddy’s is in place.

· Ensure site readiness for regulatory inspections at External suppliers where appropriate.

· Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc), ensure investigations are correctly executed.

• Developed strong organizational and communication skills through coursework and volunteer activities.
• Assisted with day-to-day operations, working efficiently and productively with all team members.
• Cultivated interpersonal skills by building positive relationships with others.
• Performing Mock audits & Review at all the formulation sites & API (Active Pharmaceutical Ingredient) of Dr.Reddys.
• Participation in Schedule Compliance Audit across the formulations and Chemical Technical Operations (CTOs) units.
• Regulatory audit response verification.
• Verification of audit response compliance at sites as per commitments.

· Lab Supporting Team - Quality Control – Oral Solid Dosage Forms

· Responsible for overall Calibrations of the QC Department.

· Standardization, Maintenance & Procurement of all WS, RS and Impurity Standards.

· Audit Trail review of Empower, UV and FTIR Instruments and closing the related issues as on date.

· User ID creations of laboratory computer systems like HPLC, GC, FTIR, UV, TLC and KF Apparatus.

· Analyst Qualifications of New Joiners, Preparation and Review of SOP’s.

· Responsible for overall activities of the Stability Department.

· Dissolution Profile comparison with innovator product, Reconstitution studies of Injectable.

· Maintenance of Stability Chambers, Incubation & Withdrawal of samples as per monthly schedule.

· Review and compilation of stability data of drug products & drug substances.