Lakshmi Kodali

Formulation - QA:

• Ensure completeness and accuracy of QA documentation, ensuring Good Documentation Practices on
  all applicable documents.
• Review and approval of protocols, reports, SOPs and Master documents.
• Responsible for preparation, review and verification of QMS system like Deviation, Change control and CAPA.
• Integrating regulatory principles by preparing and submitting the relevant regulatory doses.
• Ensuring compliance to Quality Agreements.
• Developing, monitoring and overseeing measures that assures control, reproducibility, reliability of manufacturing and testing process.
• Preparation & review of the Annual Product Quality review reports.
• Responsible for supporting documentation work related to Internal Audits, Customer Audits & Regulatory requirements.
• Handling dispatches of Formulations.

API - DQA:

• Experience in training internally & providing guidance to CROs to meet desired Quality Agreements.
• Experience in reviewing the production batch records, testing results, and related documents and preparing the required documents for product release.
• Experience in handling of vendor qualification activities and audits as needed.
• Accountable for Writing/reviewing and approval (as required) of detailed quality investigations and provide support to production with root-cause analyses.
• Coordination with cross-functions teams for timely closure of non-conformance to ensure that corrective and preventive actions are initiated.
• Demonstrates imminent customer service skills and the ability to collaborate with all levels of the organization, internally and externally.

• Check prescriptions for proper dosage.
• Responsible to dispense prescribed pharmaceuticals to customers or to other health care professionals and advise them on indications, contra-indications, adverse effects, drug interactions and dosage.
• Maintained medication profiles of customers including registry of poisons and narcotic and controlled drugs.
• Ensure proper preparation, packaging, distribution and storage of vaccines, serums, biologicals and other drugs and pharmaceuticals.
• Responsible to place the order and maintain stock of pharmaceutical supplies.
• Advise customers on selection and use of non-prescription medication.
• Renew existing prescriptions in limited circumstances.