QA (QMS & GMP COMPLIANCE) TEAM

PT SKPLASMA CORE INDONESIA; Jawa Barat; On-site; IDR 223,200,000 - 357,120,000; Full time

Job summary

PT SK Plasma Core Indonesia seeks a QA/QMS lead to establish and operate the Quality Management System for a new biopharmaceutical facility. You will develop QMS, SOPs, and document control, and drive CAPA, change control, and deviation management.

Experience in GMP pharma, CCS, and technology transfer, plus fluent English and Korean, is required to coordinate with SK Group and Indonesian health authorities.

Qualifications

• Minimum bachelor's degree in pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering or any related fields.
• 3-5 years experienced in the establishment/operation of QMS and GMP compliance in the Pharmaceutical Industry
• Proficiency in English (both written and spoken)
• Experienced in QA Department in the Biopharmaceutical Industry
• Experienced in the initial setup and operation of QMS in a newly constructed Biopharmaceutical Facility
• Experienced in the establishment and management of CCS
• Experienced in technology transfer process
• Proficiency in Korean

Responsibilities

• Establishment and operation of Quality Management System (QMS)
• Preparation of SOPs including product specification, Batch record, registration documents
• Document control
• Change control/Deviation management/CAPA management
• Training management: Training planning and scheduling, training record management

Skills

QMS Establishment

GMP Compliance

SOP Preparation

Document Control

CAPA Management

Change Control

Training Management

Training Planning

Training Records

CCS Establishment

Technology Transfer

Korean Language

English Language

Education

Bachelor's degree in Pharmacy/Pharmaceutical Sciences/Biology/Biotechnology/Microbiology/Chemistry/Chemical Engineering

Job description

SK Plasma has grown steadily on the foundation of PDMP (plasma-derived medicinal products) business starting from 1970. In 2015, SK Plasma resolved to build a state-of-the-art plasma fractionation plant and has spun off from SK Chemicals Life Science biz., aiming to improve competitiveness in the global PDMP market. SK Plasma is building a plasma fractionation plant in order to improve the self-sufficiency of PDMP in Indonesia through a joint venture with capable business partners under the support of the Indonesian government.

Role Description:

1) Establishment and operation of Quality Management System (QMS)

Preparation of Standard Operating Procedure (SOP) including product specification, Batch record, registration documents

Document control

Change control/Deviation management/CAPA management

2) Training management

Training planning and scheduling

Training record management

Requirement:

Minimum bachelor's degree in pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering or any related fields.

3-5 years experienced in the establishment/operation of QMS and GMP compliance in the Pharmaceutical Industry

Proficiency in English (both written and spoken)

Experienced in QA Department in the Biopharmaceutical Industry

Experienced in the initial setup and operation of QMS in a newly constructed Biopharmaceutical Facility

Experienced in the establishment and management of CCS

Experienced in technology transfer process

Proficiency in Korean

SK Plasma Core Indonesia, part of South Korea’s SK Group, is a biopharmaceutical company specializing in plasma-derived medicines that treat hemophilia, immune deficiencies, and severe bleeding disorders. In partnership with Indonesia’s Ministry of Health, SK Plasma is establishing a plasma fractionation plant in Indonesia to secure local production of life-saving treatments. More than a single project, SK Plasma is committed to building a sustainable presence by transferring expertise, supporting plasma donation programs, and ensuring reliable access to vital medicines made from plasma donated by Indonesians, for Indonesians.

SK Plasma Core Indonesia, part of South Korea’s SK Group, is a biopharmaceutical company specializing in plasma-derived medicines that treat hemophilia, immune deficiencies, and severe bleeding disorders. In partnership with Indonesia’s Ministry of Health, SK Plasma is establishing a plasma fractionation plant in Indonesia to secure local production of life-saving treatments. More than a single project, SK Plasma is committed to building a sustainable presence by transferring expertise, supporting plasma donation programs, and ensuring reliable access to vital medicines made from plasma donated by Indonesians, for Indonesians.