Swathi D Email & Phone Number

Hyderabad, Telangana, India

Medical Devices Complaint Management.

Goa, India

Sterile injectables Quality Assurance , QMS, Audit and Compliance

Goa, India

QMS, Market Complaint

Bengaluru Area, India

• Preparation & Review of all Tech Transfer Protocol and Report.• Change Control Management.• Logging and Handling the investigations for deviations, OOS and providing CAPA. • Preparation and Review of MFR, BMR and Batch Packing Records.• Handling of Training Management System (Training Master Application).• Preparation and Maintenance of Standard Operation Procedures.• Creation of API and Excipient material codes.• Provide support to the various divisions for effective and efficient implementation of the Quality Management System. • Ability to handle Cleaning and Process validations. • Handling of product complaints and providing CAPA. • Assist in Internal and External Quality Systems Audits and the CAPA implementation. • Interact and Co-ordinate with Production, QA, QC, Warehouse and Maintenance for effectives execution of the batches and timely delivery of the documents.

Hyderabad Area, India

Contract Management Role: • Preparation and review of Submission Batch Protocols and Reports, Sampling Protocols and Reports, Stability Protocols, Hold Time Study Protocols and Reports.• Preparation of Standard operating procedure, Equipment operating procedure, Instrument operating procedure, Equipment cleaning procedure.• Updating of Master list of documents.• Handling of Training Management System and preparation of Training Plan and effective fulfilment of Training Gaps.• Impart Training on SOP’s, Protocols, and organizational policies& procedures.• Creation of API and Excipient Material codes in SAP.• Ensuring reconciliation and effective tracking of approved protocols, validation execution from validation start point to end point, data/document compilation, and preparation of validation report with summary, errors identified.• Execution and monitoring of Feasibility / Scale up / Exhibit or Process qualification batches for submissions.• Execution of Experimental / Placebo batches for root cause analysis of scale up / exhibit batches.• Execution of the process optimization and exhibit batches protocols.• Assist the manager in compliance of Quality systems (change controls, deviations, Incidences etc). • Lead periodic reviews and implement a lean and efficient document and transfer process.• Lead scale-ups, tech transfers, validations and technical interventions.• Participation in validation activities for ensuring compliance to approved protocol and on line documentation.• Preparation of all relevant documents required for site transfer of a product.• Preparation of Batch Manufacturing Records and Batch Packaging Records.• Preparation of Quality Documents (Auditable & Regulatory).• Preparation of Reports & Protocols like Process Validation, Process Verification, Hold Time Study, Stability Protocols.

M.Pharm, Pharmaceutical Sciences

Post Graduate Diploma - Clinical Research And Clinical Data Management, Clinical Research Coordinator

Bachelor Of Pharmacy (B.Pharm.)