Sahril Siregar
Quality Assurance Officer at PT. SIXMURS PERDANA- Claim this Profile
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Bahasa Inggris Professional working proficiency
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Bahasa Indonesia Native or bilingual proficiency
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Rumpun bahasa Batak Native or bilingual proficiency
Topline Score
Bio
Franky Franky
Profesional dalam bekerja. Mampu bersaing dalam lingkungan baru. Adaptable dan Cooperative. Berani mengambil resiko pekerjaan baru dengan susunan kinerja yang baik. Memiliki Time Management yang sangat baik, dan mengorganisir tugas dan kinerja dengan baik.
Franky Franky
Profesional dalam bekerja. Mampu bersaing dalam lingkungan baru. Adaptable dan Cooperative. Berani mengambil resiko pekerjaan baru dengan susunan kinerja yang baik. Memiliki Time Management yang sangat baik, dan mengorganisir tugas dan kinerja dengan baik.
Franky Franky
Profesional dalam bekerja. Mampu bersaing dalam lingkungan baru. Adaptable dan Cooperative. Berani mengambil resiko pekerjaan baru dengan susunan kinerja yang baik. Memiliki Time Management yang sangat baik, dan mengorganisir tugas dan kinerja dengan baik.
Franky Franky
Profesional dalam bekerja. Mampu bersaing dalam lingkungan baru. Adaptable dan Cooperative. Berani mengambil resiko pekerjaan baru dengan susunan kinerja yang baik. Memiliki Time Management yang sangat baik, dan mengorganisir tugas dan kinerja dengan baik.
Credentials
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Implementation ISO 11135:2014 Sterilization of health-care products-ethylene Oxide
SGSMar, 2023- Oct, 2024 -
Awareness and Internal Audit of ISO 19011:2018
TÜV Rheinland GroupFeb, 2023- Oct, 2024 -
Awareness and Internal Audit of Quality Management System ISO 9001:2015
TÜV Rheinland GroupFeb, 2023- Oct, 2024 -
Guidelines of GMP Certification Service for Household Health Supplies (PKRT)
Ministry of Health of the Republic of IndonesiaJan, 2023- Oct, 2024 -
Awareness of Risk Management System ISO 13485:2016
TÜV Rheinland GroupAug, 2022- Oct, 2024 -
Awareness of Risk Management System for Medical Devices ISO 14971:2019
TÜV Rheinland GroupAug, 2022- Oct, 2024 -
Food Safety & Quality Management System
BADAN PENGAWAS OBAT DAN MAKANANJul, 2022- Oct, 2024 -
Good Manufacturing Practices, Quality Management System, and Food Safety
BADAN PENGAWAS OBAT DAN MAKANANDec, 2021- Oct, 2024 -
• Implementation of Halal Assurance System and Halal Regulation Update in Indonesia
IHATECOct, 2021- Oct, 2024
Experience
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PT. SIXMURS PERDANA
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Indonesia
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Hospitals and Health Care
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1 - 100 Employee
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Quality Assurance Officer
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Feb 2021 - Present
• Act as The Government’s Regulatory Consultant for global companies in Indonesia. • Ensure and provides input on regulatory-related issues associated with compliance and achieving the business plan to comply with local regulatory updates, guidelines, new regulations, and implementation. • Building and maintaining relations (including coaching clinic, consultations, discussions, and negotiations) about product, quality, and facility regulations with these Government Authorities: BKPM/ Ministry of Investment, Ministry of Health, BPOM/NFDA, BBPOM/LFDA, Ministry of Religion, LPPOM MUI, IHATEC, BPJPH, International Standard Organization (ISO), DPMPTSP. • Ensure the implementation of Quality Management System (QMS) with exposure to the best technical practices, especially in Good Manufacturing Practices/GMP (CPOB, CPAKB, CPKB, CPPKRTB, CPPOB); Good Distribution Practices/GDP (CDOB, PBF License, CDAKB, IPAK/SDAK/IDAK, PSB, SMKPO), OSS, Halal, K3, ISO. • Ensure the implementation of Good Documentation Practices (GDocP) to comply with related business processes and policies, and not limited to the following divisions: PJT/APJ, Production, Halal Supervisor, QA, RA, HR, GA, Warehouse, Logistics, Supply Chain, Technician, Sales & Marketing. • Preparing, coordinating, submitting, and monitoring regulatory applications to the relevant authorities. • Develop programs, training, and evaluating quality training subject to the defined timeline by the business processes within the scope of GMP, GDP, GDocP, Halal, and K3. • Act as the lead auditor, auditor, or auditee in internal audit or external audit activities. • Identify and resolve field quality issues and drive continuous improvement to comply with standards and regulations. • Conduct management review activities with top management (Directors, CEO, Shareholders) and key personnel positions (Level Manager, Supervisor, Assistant Manager, Officer/Staff, and/or third party (if any)). Show less
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Rumah Sakit Umum Pusat H. Adam Malik
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Indonesia
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Hospitals and Health Care
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100 - 200 Employee
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Pharmacist Intern
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Mar 2020 - May 2020
Job Desc: Pharmaceutical services in the ward and depot of the hospital. Achievement: excellent score from the head of the hospital pharmacy installation. Job Desc: Pharmaceutical services in the ward and depot of the hospital. Achievement: excellent score from the head of the hospital pharmacy installation.
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Pharmacist Intern
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Jan 2020 - Feb 2020
• Focusing on technical practices for these departments: - Production: production flow and space implementation, drug error supervision, and provided repair solutions. - QC: raw material, production processes, and drug stability supervision. - QA: drug errors supervision before release, document supervision, product validation. Achievement: excellent score on the final test from the Manager of Planning. • Focusing on technical practices for these departments: - Production: production flow and space implementation, drug error supervision, and provided repair solutions. - QC: raw material, production processes, and drug stability supervision. - QA: drug errors supervision before release, document supervision, product validation. Achievement: excellent score on the final test from the Manager of Planning.
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Pharmacist Intern
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Dec 2019 - Dec 2019
Job Desc: Pharmaceutical services on prescription (compounding, packaging, counseling) Achievement: hit the pharmaceutical science conference to doctors, dentists, midwives, and nurses, and an excellent score from the head of the public health center Job Desc: Pharmaceutical services on prescription (compounding, packaging, counseling) Achievement: hit the pharmaceutical science conference to doctors, dentists, midwives, and nurses, and an excellent score from the head of the public health center
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PT. Kimia Farma Apotek
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Indonesia
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist Intern
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Oct 2019 - Dec 2019
Job Desc: Pharmaceutical services on prescription (compounding, packaging, counseling), spreading, and dropping. Achievement: joined pharmaceutical services in BI prescription, contributed to the pharmacy development conference Job Desc: Pharmaceutical services on prescription (compounding, packaging, counseling), spreading, and dropping. Achievement: joined pharmaceutical services in BI prescription, contributed to the pharmacy development conference
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Head of Botanical Laboratory Assistant
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Sep 2016 - May 2019
Job Desc: - Shared knowledge with practitioners (junior pharmacy) - Recruited and trained new laboratory assistants - Designed and scored laboratory examination - The biology research team Achievement: increased the passing rate to 100% Job Desc: - Shared knowledge with practitioners (junior pharmacy) - Recruited and trained new laboratory assistants - Designed and scored laboratory examination - The biology research team Achievement: increased the passing rate to 100%
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Education
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Universitas Sumatera Utara
Profession, Pharmacist / Apothecary -
Universitas Sumatera Utara
Bachelor's degree, Farmasi -
Universiti Kebangsaan Malaysia
Student Exchange, Farmasi