- West Java Province, Indonesia, ID
- [email protected]
Coordinate and supervise daily activities in QC operational to ensure quality of the test results.
* Organize and ensure that testing of raw materials, bulk blends, finished goods, validation samples, study samples, environment, water, clean steam, oil free air monitoring samples, and stability samples are performed in accordance with approved test method and ensure on time testing completion.
* Supervise the environment monitoring program in aseptic area, non sterile production area, sampling booth, dispensing area, Microbiology Lab area, personnel monitoring, water, clean steam, and oil free air monitoring program, to ensure monitoring is performed according to the approved schedule and procedures.
* Review test results and ensure the reported test results are correct.
* Prepare or review specifications, Standard Operating Procedures (SOP), test procedures, and other documents
* Supervise the daily scheduling/ activities of Analysts and Lab helper, and assist the subordinates on Microbiology technical matters
* Coordinate Microbiology Analyst qualification process (training and evaluation)
* Ensure that re-testing of raw materials are carried out on schedule
* Prepare Laboratory investigation in case of out of spec and prepare annual trend report of laboratory investigation.
* Coordinate completion of corrective and preventive actions (CAPA) related to Laboratory area as commitment
* Ensure that all required equipments, reagents, reference standard are always available in adequate quantity and that they are correctly utilized
* Control cleanliness of equipments and working area.
* Ensure that calibration status of analytical instruments/ equipments are valid
* Ensure that all reagents, media, reference cultures, reference standards, bioindicator are valid and stored according to requirement
* Prepare the purchasing request of glassware, reagents, media, reference cultures, bioindicator, reference standard and stationary required
* Prepare trend analysis report of environment (aseptic area, non sterile production area, dispensing booth, laboratory monitoring), water, clean steam, and oil free air monitoring according to the defined schedule.
* Prepare data trend analysis of product prefiltration bioburden and sterility testing results on annual basis
* Support Supervisor in preparing the method validation/ verification master plan on annual basis.
* Prepares annual report of :
- Qualification status of laboratory equipment
- Validation status of QC method
- Status of Analytical Method Transfer (AMT) if any
* Support Lab Supervisor for coordinating AMT, validation/ verification of test method, and qualification of equipments.
* Support Lab Supervisor for developing annual Lab training program and coordinate execution of Lab training program
* Support Production Dept for gowning qualification of aseptic personnel
* Prepare compliance analysis report of Laboratory PQS
* Prepare Laboratory metrics on monthly basis and maintain the database (such as water and clean steam metric, LIR metric, metric of product with Microbiology test)
* Perform periodic review of Lab's SOP
* Coordinate retention of Lab's records and documents in accordance with retention policy.
* Control laboratory waste decontamination and disposal to ensure proper handling and decontamination/ disposal process
* Support Lab Supervisor in provide data for assessment of environmental aspect and impact related to QC activities
* Identify and conduct/ coordinate the continual improvement projects .
* Support process validation, qualification, or study activities.
* Support media fill activities of aseptic lines.