Junior Associate/ Associate - Drug Substance - Malaysia

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Job Description

Job Description:

To monitor compliance with the requirements of Good Manufacturing Practice.
To ensure the instructions relating to production operations are strictly followed.
To update the real time data entry in BMR'S, CKL, LS, ECC and other documents in Buffer Preparation Area / Purification 1/Reaction
To execute equipment qualification protocols and validation protocols.
To perform and document operations in accordance with cGMP.
Maintenance and calibration of production equipment and instrumentation in co-ordination with maintenance department.
To comply with EHS policies and procedures.
Responsible for OTIF execution of all the activities related to Downstream (Buffer Preparation).
To ensure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.
To ensure that the required initial and continuing training of PDS-Downstream personnel is carried out and adapted according to need.
Preparation or modification of Batch Manufacturing Records, SOP, EOP, Checklists, Log Sheets and related documents.
Data owner for process equipment used in day-to-day activity

Job Requirement:

Bachelor's degree in Chemical Engineering, Biochemistry, or related field.
02 years of relevant working experience; fresh graduates are encouraged to apply.
Good communication and teamwork abilities.
Self-motivated, responsible, and able to adapt to new processes quickly