Job Description

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

MAIN PURPOSE OF THE ROLE

• PerformQCinstrumentsqualification

• CoordinatetheactivitiesofTest Method Development,Test Method Validation / Verification,TestMethodTransfer,testing ofprocess validation and cleaning validationsamples

• Perform compendial review activities to ensureQCcompliancestate

• Support QC Manager in coordinatingQC Laboratory Operational Continuous Improvement programs

• Perform QC LaboratoryTestingFunction

• 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

• Recordreagentsstocks, and make sure allreagentsstock is wellmaintained, and all are within its expiry date.

• Calibrates all ofequipmentused inlabaccording todefinedschedule.

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

• Coordinate test method validation and method transfer

2. Performs LaboratoryComplianceFunction and support

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

• Run plans toidentify,monitorand implement continuous improvement programs of QC Laboratory Operations.

• Ensure thatrelatedcopy BOPofeach 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 wellmaintained

• Ensure that balance water pass is in thecenterposition

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

• Actively involved inmaintaininglaboratory compliance program in Laboratory

• Ensure laboratory housekeeping is wellmaintained

• Activelyparticipatedin Continuous Improvement program in Laboratory

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

• Participates in investigating any problem andparticipatesin solving out theproblem

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

• Perform stability testing and monitoringprogram

• Perform QC Equipment Qualification/Calibrationprogram

• Perform QC Test Method Development and Validation or Method Transferactivities

• 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 QualificationCalibration and Test Method Development and Validation

QUALIFICATIONS

• 3Years’ 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.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Indonesia > Depok : Cimanggis QA/Labs

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable