Provides professional services on Record Management and Decommissioning for pharmaceutical, biotechnology and chemical industries field.Key Contributions: Successfully led the project team and fulfilled the responsibilities to finish the Decommissioning and Retirement Project of P.T. Merck Sharp & Dohme (MSD) Pharma Indonesia in efficient manner and met client expectation. Supported the Decommissioning and Retirement Project of Oss Pharma (MSD) Netherland.

Conduct investigation on deviation, provide product impact assessment and problem solving recommendation, monitor GMP implementation, and ensure all finished products always meet quality criteria prior releasing to the customer.

Responsible for:Preparing APQR (Annual Product Quality Report) and assessing product trend to see possibilities of improvement. Conducting System Nonconformance (SNCR) investigation, provide impact assessment and product disposition recommendation.

Responsible for:1. Making sure that the manufacturing process comply with FDA and Health Canada standard.2. Implementing Quality by Design for New Product (Pharmaceutical and Natural Health Product)3. Designing process capability on solid line4. Supporting solid product process and cleaning validation activities

Responsible for managing all production activities including solid, semi solid, beta lactam and cosmetics line, improving production efficiency, and troubleshooting production process.Achievement:- Accomplished marketing forecast at 2013 and 2014- Invited as a speaker at International Society of Pharmaceutical Engineering (ISPE) Student Chapter annual conferences.I was also actively involved in teaching at Gadjah Mada University School of Pharmacy at Pharmaceutical Industry course (3 credits). Responsible for three topics: Plant Design, Validation, Manufacturing Process and Quality Management,

It is a pharmaceutical company that been certified by HSA (member of PICs), Gulf Central Committee for Drug Registration (member of ICH), Biohaztec USA for veterinary vaccine, and National Drug Authority of Uganda.My responsibility was managing all validation activities include utility, Equipment, Computer, Process, and Cleaning Validation to all Sanbe Plants:a. Unit I (Non Betalactam Plant)b. Unit II (Betalactam and Cephalosporine plant)c. Unit III (SVP & LVP)d. Unit IV (oncology plant)e. Veterinary Plantf. Sex Hormone Plantg. Caprifarmindo Laboratories Plant (Pharma plant and Veternary Plant)Also contribute on the start up of the Biological Product Plant Project, BSL-3 for Avian Influenza Vaccine Plant, and SPF Egg (Specific Pathogen Free) Plant.Achievement:- Successful start up Oncology Project Plant on January 2012- Successful audit for National Agency for Drug and Food Control of Indonesia- Successful audit from Health Sciences Authority of Singapore, National Drug Authority of Uganda, and Ivory Coast, Gulf Central Committee for Drug Registration, Kazakhstan Ministry of Health. - Successful audit from GlaxoSmithKline, Organon, Schering Plough/MSD, Sanofi Aventis for toll in manufacturing. Organon and MSD follow up with toll in agreement.

It is a manufacturing facilities that been certified by Health Sciences Authority of Singapore (Member of PIC/s), Gulf Central Committee for Drug Registration (ICH) and National Drug Authority of Uganda.Responsible for managing supply of all range non sterile products (tablet, capsule, syrup, dry syrup, cream, ointment, gel, suppository, effervescent), leading in improvement production process efficiency, and ensuring implementation of CGMP to all production elements.Achievement:- Successful to maintain supply performance of Capri Pharma products based on marketing forecast.- Successful for HSA (PIC/S Member) Certification for Solid Products on October 2009- Zero finding in NDA Uganda Audit and MOH (Ministry of Health) Latvia Audit in 2009 and 2010

Responsible for conducting Internal Audit, handling product complaint, handling CAPA (Corrective and Preventive Action) of Audit which is to be a part of continuous improvement, developing Annual Product Review, and conducting Basic GMP Training for all employees.Achievement:- Grade A for Capri Pharma on December 2006 (Pharmaceutical Industry Mapping from BPOM/ Local FDA)- Quality System Improvement for Capri Pharma Plant and Sanbe Sterile Plant- Successful for HSA (PIC/S Member) Certification Sterile Products (LVP/SVP) Sanbe Sterile Plant on April 2008