CURRICULUM VITAE

Erniwijayanti, Pharmacist.

Kriyan RT 120-36, Hargorejo, Kokap, Kulonprogo, D.I.Yogyakarta

erniwijayanti8335@gmail.com
085643239727 (phone and Whatsapp)

Education  Gadjah Mada University (Bachelor Degree, Majoring in Pharmacy)

Graduated in 2013
 Gadjah Mada University (Professional Degree, Pharmacist)
Graduated in 2014

Experience  PT. SANBE FARMA Unit I - Non Sterile Preparation Plant (QA
Pharmacist)
Sep 2014 – Apr 2017
 PT. CAPRIFARMINDO LABORATORIES-member of SANBE
GROUP (QA Manager)
Apr 2017- Maret 2019
 PT. CAPRIFARMINDO LABORATORIES-member of SANBE
GROUP (Head of Quality)
April 2019- Present

Workshop &  Training Excelence Program held by PT Sanbe Farma

Training (Bandung, Dec 2014)
 Training TOC held by Agilent
(Bandung, Jun 2016)
 Gas Chromatography, Analytical Method Transfer & Handling Out-of-
Specification (OOS) Data in GMP Environment held by USP PQM
(Bandung, Mar 2017)
 ISO 9001 : 2015 Preliminary Management Review held by PT. Delta
Cipta Mandiri
(Bandung, Apr 2017)
 Training Kemenkes : Sosialisasi Produksi PKRT
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 (Jakarta, May 2017)
 Demo and Introduction of electronic Quality Management System held
by Factory Talk
(Bandung, Sep-Okt 2017)
 Data Integrity held by ISPE Indonesia Affiliate
(Jakarta, Nov 2017)
 On Site Product Dossier Assessment held by USP PQM
(Bandung, Mar 2018)
 Pharmaceutical Quality System held by ISPE Indonesia Affiliate
(Jakarta, Mar 2018)
 Contamination & Cross-contamination Control in Multi-Product
Facilities held by ISPE Indonesia Affiliate
(Jakarta, Jul 2018)
 Risk Based Approach for Stability Testing Chamber Used in Stability
Studies held by HISFARIN PD IAI Jawa Barat
(Bandung, Jul 2018)
 Data Integrity, Computer System Validation, and Good Storage
Practice held by USP PQM Indonesia (Bandung, Aug 2018)
 Quality Risk Management and Good Storage Practice held by USP
PQM Indonesia (Bandung, Dec 2018)
 Menuju Pharma 4.0 dengan Penerapan CPOB Terkini held by QA-QC
Manager Geoup (Jakarta, Jan 2019)
 Computerized System Validation held by USP PQM Indonesia
(Bandung, Feb 2019)
 Sosialisasi Standar Mutu dan Regulasi di Bidang Obat kepada Pelaku
Usaha held by BPOM RI (Jakarta, Jul 2019)
 An Audit Approach to Address Microbial Contamination in Process
Equipment (ISPE Indonesia, October 2019)
 Third Party Audit (ISPE Indonesia, November 2019)
 Equipment Cleaning Process Development – Where and How To Start
(ISPE Indonesia, May 2020)
 Impurities : What Should We Know? A Case Study of Nitrosamine
(ISPE Indonesia, July 2020)
 Computer System Validation (ISPE Indonesia, August 2020)
 Ensuring A Succesful Cleaning Validation (ISPE Indonesia, October
2020)
 Remote Audit (ISPE Indonesia, October 2020)
 Powerful Statistical Tools for Pharmaceutical Industry (ISPE
Indonesia, November 2020)
 Continous Verification and Monitoring of Cleaning Process (ISPE
Indonesia, December 2020)
 Quality Risk Management as an Essential Element in the Era of
Quality 4.0 (ISPE Indonesia, December 2020)

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  Point to Consider and Line Design Elements for Pre-Use Post
Sterilization Integrity Test (ISPE Indonesia, February 2021)
 Pharma 4.0. part 1 : Driving Digital Transformation to Achieve
Business Agility (ISPE Indonesia, February 2021)
 Best Practices and Case Studies in Cleaning and Disinfection Program
(ISPE Indonesia, March 2021)
 Data Integrity (Elpharma Multi Solution, March 2021)
 Temperature Qualification for Storage of Pharma Products
Temperature Qualification for Storage of Pharma Products (ISPE
Indonesia, April 2021)
 Sampling Inspection Using AQL (Elpharma Multi Solution, August
2021)
 Process Validation : Continued Process Verification (Elpharma Multi
Solution, August 2021)
 Training dan Uji Kompetensi Penerapan SISTEM Jaminan Halal
(IHATEC, June 2022)
 Change Management (QA-QC Managers Group, June 2022)
 Temperature Mapping (Elpharma Multi Solutions, Januari 2023)
 Sosialisasi PERBPOM No.32 tahun 2022 tentang Kriteria dan Tata
Laksana Registrasi Suplemen Kesehatan (BPOM RI, March 2023)
 Sosialisasi PERBPOM No.2 tahun 2023 tentang Pedoman Pengkajian
Keamanan dan/atau Mutu Obat dan Bahan Obat terhadap Cemaran
Nitrosamine (BPOM RI, March 2023)

Scope job activities :

1. Non sterile production of human product (drugs for solid, semisolid, and liquid product,
health supplement, cosmetic, health device)
2. Handling toll manufacturing (sterile and non sterile product betalactam and non betalactam,
biological product, and veterinary product)
3. Halal Assurance System (Penyelia Halal)

Jobdescription overview :

No Description Activity
General Responsibilities
1. Quality management procedures Generate and administer
2. Management of optimum quality outcomes for Administer monitoring program and
processing, manufacturing systems and quality Quality Assurance systems
management
3. Product manufacturing Review procedures related

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 4. Finished products for deviation report Release and reject
5. Audit (internal and external) program Ensure implementation and
participate of audit program
6. Corrective and preventive action program Develop and implement
7. Deviation report Give recommendation, disposition
and approval
8. GMP training employess Ensure implementation
9. Audit Third Parties of raw material and Ensure implementation and make
packaging material agreement on specification with them
10. Documentation system Ensure implementation and system
development
11. Validation and qualification protocol and Review and approve
reports
12. Change control related to product quality Review and approve
13. Quality systems Lead, direct and co-ordinate to ensure
implementation
14. Staff organization, development and training of Responsible and ensure
people in the department implementation
15. OOS Investigation report Review and give disposition
16. Complaint investigation report Approve
17. Product Quality Review Review and approve
18. Subordinates Selecting and appraise
19. Quality monthly report Prepare
20. Continuous Quality improvement program Develop
21. Support on schedule target Working together with other
department
22. CAPA report Review and approval
23. Finished products Evaluate batch record and batch
Release (Final review, release or
rejection)
24. QC procedures (sampling instructions, Approve
specification, test methods & other QC
procedures)
25. Analysis carried out under contract Approve and monitor
26. Department & equipment Check maintenance
27. Validation programmes & analytical Lead & ensure implementation
procedures and calibrations of control
equipment

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 28. Site Master File and Quality Manual Review and preparation
29. Validation Master Plan and SOP related to Approve
quality
30. Risk asessment Evaluate and approve
31. Manufacturing Resource and Planning Coordinate for any rule
program (MRP) related activity
32. Holding time study, transportation study and Review and approval
any other studies related to quality
33. Recall products and mock up recall programms Coordinate
34. Certificate of Analysis for finished product Approve
35. Management review Participate
World Health Organization (WHO) Responsibilities
1. General Responsibilities Responsible to all General
Responsibilities
2. Communication and inform WHO Become WHO contact person
3. Stated timelines or request WHO and notify Correspond with WHO
WHO of the date of expected communication
4. GMP inspection at the specified manufacturing Send an invitation for WHO
site
Halal Assurance System (Penyelia Halal)
1. Planning of Halal Assurance System Implementation
2. Implementation of Halal Assurance System
3. Evaluation of Halal Assurance System

Erniwijayanti, Pharmacist

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