Deepthi Valaparla Email and Phone Number

Handling of Market complaints: Ensuring the market complaints received are adequately investigated with appropriate root cause analysis and necessary corrective and preventive actions are taken for the same as per the standard operating procedures and follow GMP and GDP (Good Manufacturing Practices and Good Documentation Practices) requirements andEnsuring to Perform Quarterly and Annual trending of Market complaints.Marketing Queries: Handling queries which were received from customers.Quality agreements.Customer questioners.Training: Qualified as a certified trainer and responsible for providing cGMP and on the job trainings.Self-Inspection: Qualified auditor and responsible for conducting Self-inspections at site.

Product quality review: Preparation & Review of Product quality review, Collection, evaluation of product quality data and assessment through 6 Sigma method, investigation, assessment and implementation of appropriate CAPA.Excel sheet validation for PpK calculation.Involved in PQR digitalization project.Continuous process verification: Review of continuous process verification reports.Handling of incidents and CAPA management: Ensuring the incidents raised are adequately investigated with appropriate root cause analysis and necessary corrective and preventive actions are taken for the same as per the standard operating procedures and follow GMP and GDP (Good Manufacturing Practices and Good Documentation Practices) requirements. The incident’s include general incidents along with product related incidents (OOS, OOT, Yield related etc.)Handling of Change controls: Ensuring any changes done with respect to the system are as per the standard operating procedures and follow cGMP (Current Good Manufacturing Practices).IPQA (In Process Quality Assurance): Responsible for online audit of the facility and online BPR (Batch Production record) review.Handling of Validations: Responsible for validations of process of a particular drug substance to assure consistency in all aspects of GMP and regulatory compliance.Self-Inspection: Qualified auditor and responsible for conducting Self-inspections at site.Vendor Qualification: Site representative for Vendor qualification activities and responsible for qualification of KSM, ORM & Packing materials.Consuables: Responsible for qualification of the consumables and maintain the approved consumables list.QA Release: Responsible for release of products in to the market through SAP.Reviewer Qualification: Responsible for qualification of reviewers and to maintain the list of reviewer’s department wise.Audits: Active involvement in Customer and Regulatory audits.

Handled wet lab instruments (KF titrator, IR instrument, LOD, ROI..etc)Preparation of specification and method of analysis.Review of Analytical raw dataActive involvements in regulatory and customer audits.

Preparation of Master batch production Records.Review of Executed batch production records.Batch ReleaseReview and approval of Validation protocols and Reports.