Experience

PT. Simex Pharmaceuticals Indonesia

• Indonesia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA Supervisor (Calibration, Qualification and Validation Supervisor)

  • Apr 2021 - Present

  I have responsibility in : • Ensure that all annual calibration, qualification and validation plans are included in the Validation Master Plan (RIV) and ensure that calibration, qualification and validation are carried out on time.• Prepare calibration schedule, carry out calibration, and prepare calibration certificate. Ensure all measuring instruments at pt simex are calibrated according to schedule.• Prepare a review related to cleaning validation and review it periodically. Prepare cleaning validation program, prepare protocols, implementing cleaning validation and making reports.• Preparing qualification programs, coordinating the implementation of qualifications, compiling qualification programs, protocols, implementing performance qualifications and compiling performance qualification reports.• Prepare PQR Document for 1 product (Myconis Drops 2018-2020) in 2021, 5 product in 2022 (GL Vit D 400 2020-2021, Lymax Syrup 2020-2021, Maxprinol Tablet 2020-2021 –closed), and (Erdomex Capsule 2021, Simfix 200 -closed) Show less

• PIC of Pharmacovigilance

  • Sep 2018 - Present

  I have responsibility in : • Establish and manage a pharmacovigilance system.• Prepare, review, socialize, and conduct training on Pharmacovigilance procedures.• Receive and follow up on complaints of drug side effects• Act as a 24 hour contact person regarding pharmacovigilance reporting.• Prepare all types of Pharmacovigilance reporting.• Prepare and provide information on the safety aspects of drugs requested by BPOM immediately in the context of a benefit-risk assessment. Show less

• QA Supervisor (Audit, Complaint and Recall Handling)

  • Jan 2018 - Mar 2021

  I have responsibility in : • Prepare self-inspection and external audit program (audit of suppliers of starting materials, packaging materials, factory/laboratory of contract recipients), participate in its implementation and ensure the effectiveness of its implementation so that it is in accordance with the predetermined schedule.• Initiating and participating in coordination meetings for the preparation of the CAPA report, helping to determine the root cause of the problem and the necessary corrective and preventive actions as well as monitoring its completion so that it is in accordance with the predetermined schedule.• Handle complaints from customers (patients, distributors, pharmacies and others) and the POM Agency.• Handle Product Return • Handle Product Recall• Handle Post Marketing Surveillance• Prepare Document for Halal Certification. Halal certification for facility and 4 supplements (2019). Halal certification for 26 suplementst (2019). Halal certification for about 40 suplement and medicinal product (2020) • Handle Raw and Packaging Material Supplier Evaluation• Handle Qualification and Evaluation to Pest Control, Analytical and Calibration Laboratory, Distributor and Expedition Service. • Handle GMP Certification for CPOB renewal Certification in 2019.• Prepare PQR Document for 1 supplement product (Imunvit KSS 2015-2017) in 2018 and 1 medicine product (Maxstan KSS 2018) in 2019. Show less

• Back Up PIC of Pharmacovigilance

  • Jan 2018 - Aug 2018

  I have responsibility in• Assist the person in charge of pharmacovigilance in carrying out their duties and responsibilities.• Act as the person in charge of pharmacovigilance if the person in charge of pharmacovigilance is unable to carry out his duties and responsibilities for certain reasons.

• QA Supervisor (Document Control and Change Control)

  • Oct 2017 - Jan 2018

  I have responsibility in : • Controlling/monitoring all documentation in the factory so that it is controlled and complies with GMP standards.• Handle change control that have impact on product quality, so that it remains controlled and validated.• Delegated by QA Manager to Review Specification Document, Working Instruction, Packaging Artwork and Colour Range. • Responsible for managing handling change control, monitoring implementation. • Responsible to prepare document for liquid and semisolid sharing facility BPOM certification (Fasilitas Bersama) (medicine & supplement sharing facility) in 2017. Show less


PT. Kimia Farma Apotek
• Indonesia
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Pharmacy Intern

  • Apr 2016 - Apr 2016

Dexa Medica (Member of Dexa Group)
• Indonesia
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Pharmacy Intern

  • Feb 2016 - Mar 2016

Suku Dinas Kesehatan Kota Jakarta Barat
• Pharmacy Intern

  • Jan 2016 - Jan 2016