Mimi Syahputri

To manage and execute assigned change projects (including transfers, divestment, pruning & due diligence activities) from initiation to execution, ensure timely supply to the markets in compliance with regulatory & cGMP requirements. Performing overall Quality assessment to any project/global change initiatives to the site

Managing Product Transfer and Process Validation; Reviewing and approving validation protocol/report, improvement study, and technical trial batches Super user SAP Quality Management on maintaining quality related aspect material master, supplier database, final approval of inspection plan Developing system for product transfer (Regulatory CMC, Product Information from giving site, etc.)

Authorized person for batch released; Responsible for developing product related system; Super user SAP Quality Management on maintaining quality related aspect material master, supplier database, final approval of inspection plan; QA Representative for any product related deviation/OOS; product related change control; Product transfer/process validation; review and approve Master Batch Record in MES Handling supplier qualification (product related supplier);

Responsible for QA Compliance, Managing investigation of quality incident, handling complaint, and managing QA routine activity, such as IPC, Product and Material release, retained sample and batch record review.

Responsible for Compliance on ensuring cGMP implementation and compliance issue, GMP Self Inspection Audit, as site lead auditor (set schedule, execution, prepare SIP audit report, follow up and closure all CAPA (Corrective and Preventive Action) audit; Registration compliance; Managing CAPA performance Internal and External; Document control; Manufacturing change request; Vendor audit (raw material and packaging material); Site lead Trackwise (World Wide CAPA Tracking System)

Responsible for performing/coordinating investigation of all quality incident (deviation and product complaint) of BMS Product and Janssen Cilag (TPM) Product,; Managing CAPA from each quality incident

Responsible for new product development, starting from searching formula/developing formula, raw material, deciding equipment to be used, and preparing its manufacturing instruction and packaging instruction (documentation). Supervise and responsible for new product development process included stability trial first 3 (three) commercial batches. As coordinator of problem solving team on handling deviation on products and or process. Performing productivity project

Responsible for all validation and revalidation activities, included; process validation, cleaning validation, OQ and PQ, system validation and computer validation; Coordinator of handling deviation on validation batch Training : •Dale Carnegie : Fundamental Leader Ship Training 2002 •Indonesian Drug and Food Bureau : Validation and Stability Workshop 2002 •Shimadzu : TOC Cleaning Validation Training 2002

Responsible for new product development, starting from searching formula/developing formula, raw material, deciding equipment to be used, and preparing its manufacturing instruction and packaging instruction (documentation). Supervise and responsible for new product development process included stability trial first 3 (three) commercial batches. As coordinator of problem solving team on handling deviation on products and or process. Performing productivity project

Supervise Pharmacist Assistant in dispensing drugs; Provide information and consultation as hospital pharmacist; managing stock for polyclinic, ICU, Radiology Room, Laboratory, and Operation Room and in hospital dispensary