Baru Microbiologist

Date Posted: 5 hari yang lalu

Salary:

North Sumatra

Industry : Manufacture Location : Sei Mangkei, North Sumatera Jo's ID : 8774 (please put in the email) Job Description:

To plan and execute Quality control activity & Good Laboratory Practices in Department.
To maintain & review Calibration matrix & Schedule.
To issue and review of Batch manufacturing Records to Operations.
To review analytical reports Batch manufacturing records before release of finished product.
Review of daily records and log book.
Preparation and review trend and annual product review reports.
Preparation of Analytical method validation protocols and its execution.
To undertake the releases of Raw and Packaging material, In-process /semi-finished and finished product.
Training new recruits/colleagues and ensure chemist qualification.
Preparation and review of SOP / STPs, protocol.
Preparation and review of RM, PM and FG specifications.
To plan and execute microbiology activities per compliance.
Plan and execute Environmental monitoring activity.
Reviewing stability schedule, stability trends and stability test reports.
Support to regulatory activity.

Requirements:

Graduate/Post Graduate in Microbiology, Chemistry/ Biochemistry/Pharmacy.
At least 5 year(s) of working experience in the related field is required for this position.
Knowledge of Out of specification (OOS) related microbiology area.
Knowledge of Good laboratory Practices standards
Knowledge of ISO 13485 & ISO 9001 and applicable regulatory guidelines.
Willing to work in Sei Mangkei, Medan