QA MANAGER

PT Cahaya Research Indonesia; Pasirsari; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A leading pharmaceutical company in Cikarang is seeking a QA Manager to oversee quality assurance responsibilities. The role involves reviewing GMP documents, performing audits, and ensuring compliance with cGMP standards. Ideal candidates should have a Bachelor of Pharmacy, managerial experience, and proficiency in English.

Benefits

BPJS

THR

Qualifications

• Minimum of 10 years of managerial experience.
• Experience in a global company.
• Experience working in sterile facilities.

Responsibilities

• Responsible for QA responsibilities as the pharmacist in manufacturing.
• Review batch records and GMP documents.
• Create procedures and systems for quality oversight.

Skills

cGMP

Quality Management Systems

Data Integrity Audits

English Communication

Result-oriented Mindset

Education

Bachelor of Pharmacy

Job description

Our client is a pharmaceutical company based in Jakarta – Cikarang.

They are looking for a professional with a pharma manufacturing background to fill the role of QA Manager in Cikarang.

QA MANAGER

Job Description

• Responsible for QA responsibilities as the pharmacist in manufacturing.
• Review batch records, including analytical reports and related documents such as marketing authorization, product specifications, retained sample checks, OOS/OOT/events/deviations/change controls.
• Review and approve GMP documents at the plant, perform quality oversight, and establish CCS.
• Review and approve documents related to technology transfer.
• Review and approve GMP documents for registration purposes (Dossier).
• Create procedures and systems, perform data integrity audits in the area.
• Create systems for collecting and summarizing Quality Key Performance Indicators.

Job Requirements

• A good honors degree, preferably Bachelor of Pharmacy (Apothecary).
• Age between 35-37 years.
• Minimum of 10 years of managerial experience.
• Experience in a global company.
• Understanding of cGMP and Quality Management Systems.
• Experience working in sterile facilities.
• Result-oriented mindset.
• Proficiency in English communication.

Salary Package

• Salary: IDR 20-25 million/month.
• BPJS, THR included.

Additional questions include expected salary, qualifications, experience, language skills, GMP experience, notice period, and travel availability.