Rozi Amelia Amnaska is a 28-year-old pharmacist living in Depok, Indonesia. She has a Bachelor's degree in Pharmacy from University of Andalas and worked as a pharmacist at PT. Sandoz Indonesia, PT. Pfizer Indonesia, and currently works as a QA Compliance at PT. Medifarma Laboratories. She is married, speaks Indonesian and English, and has over 10 years of experience in the pharmaceutical industry focusing on quality assurance, validation, auditing, and compliance.

1. Rozi Amelia Amnaska, S.Farm., Apt.
Perumahan Permata Puri 4 Blok A2
RT 008/RW10,
Mekarsari, Cimanggis, Depok
Hp. 085669089150, Email: rozi.amnaska@gmail.com
PERSONAL DETAILS
Full Name : Rozi Amelia Amnaska, S.Farm., Apt.
Age : 28 years old
Place / Date of Birth : Jakarta / March 9th
1988
Address : Perumahan Permata Puri 4 Blok A2, RT 008/RW10,
Mekarsari, Cimanggis, Depok
Phone : 085669089150
E-mail : rozi.amnaska@gmail.com
Status : Married
Nationality : Indonesian
Religion : Islam
Weight/Height : 50 Kg/160 cm
FORMAL EDUCATION
Sept 2010 - Juli 2011 : Pharmacist, Majoring Apothecary Profession, Andalas
University . With Last GPA 3.45.
2006 - 2010 : Bachelor Degree, Majoring in Pharmacy, University of
Andalas. With Last GPA 3.11.
2003-2006 : High School Degree, Majoring in Natural Science SMA Negeri
39 Jakarta.
2000-2003 : Junior High School, SLTP Negeri 184 Jakarta.
1994-2000 : Elementary School, SDN Pekayon 10 pagi, Jakarta.
NONFORMAL EDUCATION
2000-2005 : Course of study in BBC English Training Specialist
2005-2006 : Course of study in PRIMAGAMA (General Study)
LANGUAGES SPOKEN
Primary Indonesia
Secondary English
COMPUTER LITERATURE
Familiar with MS Office (MS Excel, MS Word, MS Power Point), Internet
Curriculum Vitae (CV)

2. WORK EXPERIENCE
- Dec 2011-June 2013 : Pharmacist in Validation and Qualification process at PT.
Sandoz Indonesia
Role Description
Implementing the activities which related to qualification of equipment, building, utilities,
computerize system validation, Audit Preparation, and other projects in Production
Department, include create the inventory list of production equipment, implementation of
Manufacturing and Laboratory In Control on the production and packaging process refer
to guideline of GMP, HSE, and industrial health standard by Novartis Group.
Responsibilities:
 Perform the qualification of equipment and systems that are the production
department responsibility, start from create the required documents for the activity of
equipment or system qualification until its release for routine operation
 Review the of qualification equipment and systems status that have been used in the
production area base on timeline, it’s refer to SOP for Equipment Qualification and
create the routine monitoring report.
 Create and update the inventory list in the production area
 Create and Complete all of Manufacturing In Control/Laboratory In Control action list,
Computerize System Validation and the other projects in the Production Department
according to the target defined
 Support for ordering of new equipment or machine in the production area and create
the User Requirement Specification (URS) document
 Collaborate with Production or Packaging Supervisor to Create and review the SOP
which related to the equipment, utilities and system in the Production area, including
SOP for Operational and SOP for Cleaning
 Collaborate with Production or Packaging Supervisor to investigate and follow up
CAPA regarding equipment/system functional and operational if there is deviated
process in the production area
- June 2013 – October 2014 : QA Specialist at PT. Pfizer Indonesia
March 2015 – Dec 2015 : QA Specialist at PT. Pfizer Indonesia
Role Description
The prime accountabilities cover activities related to update and maintain QA’s
documentation/ database and SOPs, review batch records regarding to product release
process, performing material and product complaint assessment, management and
annual trend, provide data for annual product review, deviation & CAPA (corrective action
& preventive action) tracking and trending, Change Request tracking, support QA
inspection activities such as IPC and material inspections.

3. Responsibilities
 Writing or updating QA’s Standard Operating Procedure (SOP) in accordance with
actual practices, PQS, current GMP, and regulatory requirements, and ensure that all
QA’s SOP are consistently followed and implemented.
 Review Batch Records prior releasing product, batch records retention and
destruction as per approved SOP.
 Handling the following activities:
- Evaluate material complaint report submitted by QA Inspector (PM Inspection) or
other department, entry to material complaint database, tracking response, and
close out status of the complaint.
- Filing for Quality Assurance Report, Event Report, Change Request & Product
Complaint and maintain the database.
- Provide data for quality metric and maintain the database of QA metrics for QAR,
CAPA and Change Request.
- Support in providing data for annual product review.
 Provide trend of Deviation (QAR & Event Report) and Trend of Material complaint
and Product Complaint for PGS and J&J Products.
 Handling the following activities:
- In-process control testing/ inspection at the production process
- Packaging line inspection
- Sampling and testing/ inspection of packaging material, imported product,
returned goods, non-inventory materials/supplies with direct/potential impact to
product quality.
 Identify and conduct continuous improvement project (Method 1) in QA area.
- January 2016 - Now : QA Compliance at PT. Medifarma Laboratories
Role Description
Responsible for the implementation of the training of GMP to all employes; coordinate and
perform self inspection and vendor audits; handling documentation of Change Control and
Quality Deviation Report (QDR); coordinating and tracking CAPA related audits, change
control and QDR; handling product complaint, coordinate the investigation, manage &
follow up CAPA related to product complaint, and create the report of Annual Product
Review (APR).

4. Responsibilities
General responsibilities:
1. Responsible for the implementation of self inspection in all area.
2. Responsible for the implementation of vendor audit.
3. Handling the documentation of Change Control and Quality Deviation Report (QDR).
4. Coordinate and tracking CAPA related audit, change control and QDR.
5. Conduct an investigation related the complaint and create report a product complaint.
6. Create the report of Annual Product Review.
7. Provide training of GMP to all employes.
8. Give an appraisal to Subordinate related their performance to be delivered to QA
Manager.
9. Participating in supporting the implementation of "best practice" in the PT Medifarma
Laboratories
Main responsibilities:
1. Create SOPs related to QA Compliance.
2. Provide GMP basic training for new employee.
3. Provide GMP Refreshment training program annually for all employees.
4. Handling self-inspection program and coordinate the implementation and participated
as an auditor in the self-inspection.
5. Handling vendor/supplier audit program and coordinate the implementation and
participated as an auditor in the vendor/supplier audit.
6. Tracking the status of CAPA related audit (internal and external) and follow up CAPA
to all departments.
7. Handling change control documentation, provides numbering of change control,
tracking the status of change control and follow up of CAPA related change control to
all departments.
8. Handling documentation of Quality Deviation Report (QDR), provides numbering
QDR, tracking status and follow up related CAPA of QDR to all departments.
9. Conduct investigations for complaints received from customers and create a
complaint report based on the results of the investigation of complaints.
10. Tracking and follow up of CAPA related complaints to all departments.
11. Create report of Annual Product Review.
12. Create monthly report related the audit, change control, QDR and complaints.

5. APPRENTICE EXPERIENCE
2011 : Pharmacist Professional Internship at PT.BINTANG
TOEDJOE, Jakarta.
2011 : Pharmacist Professional Internship at SUMBAR
Pharmacy, Padang.
2011 : Pharmacist Professional Internship at RS.Dr. ACHMAD
MOCHTAR, Bukittinggi.
SEMINARS AND TRAININGS
 Seminar Nasional “Pengembangan Potensi Farmasi dalam Pelayanan Konsumen
Kesehatan dan Kewirausahaan” pada Pramunas XII ISMAFARSI, Universitas Andalas
(Padang – 2008).
 Final project research in the Laboratory of Physical Pharmacy Biopharmaceutical and
Pharmacokinetics, Andalas University about “Formulation of Roselle Extract Peel Off
Mask Using Chitosan Transformed from Dried Shrimp Sheels of Metapenaeus monoceros
fabricus as a base. (2010).
 Workshop dengan tema “ Keselamatan Kerja di Laboratorium” sebagai rangkaian acara
PHARMACY WEEK “Pharmacy Without Borders” yang dilaksanakan oleh Himpunan
Mahasiswa Farmasi Universitas Andalas (2006).
 Workshop dengan tema “Generasi Muda Menyambut Teknologi Informasi, Kelompok
Pengguna Linux Indonesia, Universitas Indonesia (Linux Goes To School)” yang
dilaksanakan oleh Himpunan Mahasiswa Fisika FMIPA Universitas Indonesia (2004).
 Kuliah Umum Kewirausahaan dengan narasumber Bapak H. Rani Ismael, Direktur
PT.Suka Fajar, Ltd., Universitas Andalas, Padang (2008).
 Pelatihan Kepemimpinan dan Manajemen Mahasiswa Farmasi (LKMMF) Universitas
Andalas, Padang (2008).
 Pelatihan Adobe Photoshop, Universitas Andalas, Padang (2009).
 Pelatihan Bimbingan Aktifitas Kehidupan Kampus dan Kegiatan Ilmiah (BAKTI)
Universitas Andalas, Padang, Sumatra Barat (2006).
 Pelatihan Bina Bakat Minat dan Kepemimpinan ke XXIII dengan tema “ Totalitas Potensi
Generasi Farmasi yang Intelektual, Spiritual dan Organisatoris Berlandaskan Semangat
Kekeluargaan”, Fakultas Farmasi Universitas Andalas, Padang, Sumatra Barat (2006)
EXTRACURRICULAR AND ORGANIZATION
Extracurricular and Organization Position Year
Pramuka Anggota 1997-1999
PMR (Palang Merah Remaja) Bendahara 2001-2002
KPTI (Kelompok Pecinta Teknologi
Informasi)
Anggota 2003-2005
Badan Eksekutif Mahasiswa FMIPA
Universitas Andalas
Staff Departemen
Informasi
2007-2008

6. APPRECIATION
 Finalis dalam kegiatan Program Kreativitas Mahasiswa Penelitian (PKM-P) dengan
judul “Formulasi Sediaan Masker Peel Off dengan bahan aktif ekstrak gambir (Uncaria
gambir Roxb) Terstandardisasi” dalam program “PEKAN ILMIAH MAHASISWA
NASIONAL” (PIMNAS) XXII yang diselenggarakan oleh Direktorat Jenderal Pendidikan
Tinggi Departemen Pendidikan Nasional (2009).
 Finalis dalam kegiatan Program Kreativitas Mahasiswa Penelitian (PKM-P) dengan
judul “Formulasi Sediaan Masker Peel Off dengan Memanfaatkan Kitosan dari Limbah
Udang” Tingkat Universitas Andalas (2010).
 Bintang AKTIVIS pada Wisuda II oleh Badan Eksekutif Mahasiswa Farmasi Universitas
Andalas (2010).
 Peraih beasiswa “Bantuan Belajar Mahasiswa” oleh Universitas Andalas, Padang
(2008-2010)
 Juara II Perolehan Nilai pada Ujian Akhir Nasional oleh Panitia Ujian Akhir Nasional
SLTP Negeri 184 Jakarta (2003).
 Juara III Lomba Matematika Tingkat Kecamatan Pasar Rebo (1999).
INTERPERSONAL
Highly motivation to go forward, responsible, creative, disciplined, honest, trustworthy,
communicative, work-hard, willing to learn about new things, and team-oriented problem
solver.
This Curriculum Vitae is prepared in valid data by my good intention to be used by any
parties needed.
Best Regards,
Rozi Amelia Amnaska, S.Farm.,Apt