PT. Mulia Farma Suci

Audit Internal
GAP Analysis
Audit External
Kualifikasi Pemasok
Recall & Mocked Up Recall
Complaint, Deviation, Change Management, QRM
Ikut serta dalam update sertifikat CPOB, CPOTB, & FasBer
PJ Pharmacovigillance II

GMP Compliance Spv

PT. Gracia Pharmindo

-Review BR and CoA
-Helping re-certification for ISO QMS 9001 : 2015
-Do coordination for CPOTB's new certification process for traditional medicine (OT) line
-Do coordination for TKDN
-Do coordination for CPOB's new certification for small volume parenteral (SVP) line
-Do coordination for ISO 9001 from URS
-Make gap analysis of existing product and NIE
-Joined SJH's team
-Joined 5S's team
-Joined as APJ Quality Assurance Traditional Medicine
-Joined as representative in charge of pharmacovigilance
-Helping QA Manager's function

Assistant Manager QA

PT. Imedco Djaja

APJ Kosmetik:
Take decision to release or reject cosmetic finished product for sale taking inti account related factors
Informing BPOM of a recall of cosmetic products due to defecta or suspected quality defects
Make a commitment letter, statement letter, & quality documents needed to fulfill cosmetic registration requirements
Provide a follow-up response to letter issued by BPOM related to quality of cosmetic products
Dia position on the release of cosmetic products if needed
Give approval to extermination plan
Coordinate with QA Dept Head

Apoteker Penanggung Jawab Kosmetik

Qualification (machine, room, facility), Calibration, Temperature Mapping, Spreadsheet Validation, Shipping Validation, and PQR

Quality Assurance Specialist

PT. CKD OTTO PHARMACEUTICALS

Handling calibration machine & HVAC Qualification
Execute & Coordinate Validation & Qualification
Prepare & review protocol validation & qualification
Prepare & review report validation & qualification
Making water monitoring and environmental monitoring annually report

Quality Assurance Supervisor

Unit 5, Biologicals Plant, PT. Sanbe Farma

Has many experiences on making VMP, SOP, protocol, report, and other related documents and executing of Validation activities at Biologicals Plant, Unit 5, PT. Sanbe Farma. Also has experience on making of QRM and CAPA documents and conducting review of BMR of media fill.

Validation Engineer

Unit 4, Oncology Plant, PT. Sanbe Farma

Has many experiences on making VMP, SOP, protocol, report, and other related documents and executing of Validation activities at Oncology Plant, Unit 4, PT. Sanbe Farma. Also conducting review of BMR of media fill.

PT. IFARS Pharmaceutical Laboratories

Validation internship : for making SOP, report of process validation and analytical method validation
RnD internship : for making QbD document

Student Internship: QA (Validation) & RnD (QbD)

A professional with 7 years of work experiences in the field of quality assurance in the pharmaceutical industry, who has developed skills in validation, qualification, calibration, and GMP Compliance.
Experiences of Apoteker Penanggung Jawab Pedagang Besar Kosmetika : responsible of cosmetics distribution

Taplio

Erlita Prastika Dewi's Linkedin Analytics

Want to drive more opportunities from LinkedIn?

Taplio

.css-1jgreyo{background-image:linear-gradient(284deg, rgba(39,43,72,1) 0%, rgba(33,47,183,1) 100%);color:transparent;-webkit-background-clip:text;background-clip:text;}Erlita Prastika Dewi's Linkedin Analytics

Want to drive more opportunities from LinkedIn?

Erlita Prastika Dewi's Linkedin Analytics