QC Specialist (Lab. Operation & Stability)

Takeda; Bekasi; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A leading global pharmaceutical company is seeking a Quality Control Coordinator in Bekasi, Indonesia. This role involves coordinating stability study activities, ensuring compliance in the QC lab, and supporting various quality assurance tasks. The ideal candidate has a Bachelor's in Pharmacy or a related field, with at least 1 year of experience or is a fresh graduate. Good understanding of GMP and GLP is essential, along with laboratory skills and proficiency in English.

Qualifications

• Fresh graduates or minimum 1 year experience in Quality Control.
• Good understanding of GMP and GLP.
• Good English competency (reading, listening, speaking).

Responsibilities

• Coordinate stability study activities of finished product.
• Lead Investigator for Laboratory Event.
• Self-inspection coordinator for QC chemical lab.
• Support PQR completion by providing stability data.
• Ensure availability of reagents for testing.

Skills

Laboratory skills

Analytical chemistry

MS Word

Excel

PowerPoint

Education

Bachelor of Pharmacist or relevant major

Job description

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Job Description

Duties & Responsibilities :

• Responsible as coordinator of stability study activities of finished product, including creating stability protocol, sample request, product sampling from chamber, review testing report, creating stability report, archiving stability study testing report, and monitoring of stability chamber and stability room.

• Responsible as Lead Investigator for Laboratory Event and Deviation.

• Self-inspection coordinator for QC chemical lab.

• Support PQR completion by providing stability data and evaluation as required.

• Support qualification activities of new QC Equipment/ Instrument (support AIQ/CSV).

• Ensure availability of reagenVconsumable/RS/WS for testing purposes as well as its compliance.

• Ensure temperature monitoring in Chemical QC Lab and conduct instrument data backup ex. Manual back up, log tag etc.

• Perform relevant Global SOP Gap Assessment, creating new or revise SOP, perform SOP periodic review at site.

• Ensure 5S, Good Documentation Practice and data integrity principles are implemented at QC Chemical Laboratory area.

• Support reviewing testing result for Finished Goods according to lead time.

Requirements :

• Fresh graduates or minimum has 1 year experience in Quality Control

• Bachelor ofPharmacist or any relevant major

• Good understanding about GMP and GLP

• Have necessary laboratory skills, including knowledge of how to perform analytical chemistry, instrumental analysis and physical chemistry

• Good English competency (reading, listening and speaking)

• Proficient in MS Word, Excel and PowerPoint

Locations

Bekasi, Indonesia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time