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MAIN PURPOSE OF THE ROLE

Perform QC instruments qualification .

C oordinate the activities of Test Method Development , Test Method Validation / Verification, T est M ethod T ransfer, testing of process validation and cleaning validation samples .

Perform compendial review activities to ensure QC compliance state .

Support QC Manager in coordinating QC Laboratory Operational Continuous Improvement programs .

Perform QC Laboratory Testing Function

Perform as QC Reviewer Function, including daily QC coordination and scheduling activity.

MAIN RESPONSIBILITIES

1. Performs Physical and Chemical Test Activities

Perform analysis for incoming material/ Intermediate/ finished product accordingly and generate laboratory worksheets and the report accurately and completely .

Perform chemical testing on stability program .

Record reagents stocks, and make sure all reagents stock is well maintained , and all are within its expiry date.

Calibrates all of equipment used in lab according to defined schedule.

Verify Equipment calibration status is available, clear and all are within calibration schedule.

Coordinate test method validation and method transfer .

2. Performs Laboratory Compliance Function and support

Perform compendial review program to ensure the compendial method and/or monograph applied at the sites are following the current compendia.

Run plans to identify , monitor and implement continuous improvement programs of QC Laboratory Operations.

Ensure that related copy BOP of each laboratory equipment/instrument is available and attached in the related logbook and ensure all are followed.

Ensure that laboratory equipment/instruments logbook equipment is filled accurately as per its BOP, completely reviewed and available near to the equipment.

Perform inspection of laboratory facility related to floors, walls, and ceilings of smooth, hard surfaces that are clean and no deterioration .

Ensure laboratory housekeeping is well maintained .

Ensure that balance water pass is in the center position .

Ensure that all glassware is clean from residue and sticker label.

Actively involved in maintaining laboratory compliance program in Laboratory

Ensure laboratory housekeeping is well maintained .

Actively participated in Continuous Improvement program in Laboratory

Performs duties as assigned by QC Supervisor or QC Manager effectively and efficiently.

Participates in investigating any problem and participates in solving out the problem

Obligates and responsible for good cooperation, work discipline, work safety and safety environment in laboratory, implement and maintain laboratory compliance, keep confidentially of all documents, and achievement on definite yearly goals.

Perform stability testing and monitoring program

Perform QC Equipment Qualification/Calibration program

Perform QC Test Method Development and Validation or Method Transfer activities

Verify raw data and worksheet generated during testing to ensure raw data completeness and correct calculation.

Coordination sampling activity with sampling technician and verify worksheet if the responsible leader is absent.

Coordinate lab activities, incoming raw material testing activities, finished product and stability product if the responsible leader is absent.

3 . Perform as QC Reviewer Function

Review and verify all QC raw data and worksheet generated by QC Analyst and Lab Technician for all type of QC Physical and Chemical testing performance.

Review and verify all QC raw data and worksheet generated by QC Analyst for QC Equipment Qualification /Calibration and Test Method Development and Validation

QUALIFICATIONS

3 Years’ experience as QC Analyst from Chemical Analyst High School or

Bachelor’s degree majoring in Chemistry or Pharmaceutical Science .

Knowledge of continuous improvement skills and methodologies.

English literacy.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

QC Team Leader (Cimanggis)