ASSOCIATE
- Malaysia
- Tetap
- Sepenuh masa
1 To monitor the compliance with the requirements of Good Manufacturing Practice.
2 To ensure the instructions relating to production operations are strictly followed.
3 To update the real time data entry in BMR'S, CKL,LS, ECC and other documents in Buffer
Preparation Area / Purification 1/Reaction
4 To execute equipment qualification protocols and validation protocols.
5 To perform and document operations in accordance with cGMP.
6 Maintenance and calibration of production equipment and instrumentation in co-ordination
with maintenance department.
7 To comply with EHS policies and procedures.
8 Responsible for OTIF execution of all the activities related to Downstream (Buffer Preparation).
9 To ensure that all production deviation are reported and evaluated and that critical deviations
are investigated and the conclusions are recorded.
10 To ensure that the required initial and continuing training of PDS-Downstream personnel is
carried out and adapted according to need.
11 Preparation or modification of Batch Manufacturing Records, SOP, EOP, Checklists, Log
Sheets and related documents.
12. Data owner for process equipment used in day-to-day activityKey ResponsibilitiesJOB DESCRIPTION
1 To monitor the compliance with the requirements of Good Manufacturing Practice.
2 To ensure the instructions relating to production operations are strictly followed.
3 To update the real time data entry in BMR'S, CKL,LS, ECC and other documents in Buffer
Preparation Area / Purification 1/Reaction
4 To execute equipment qualification protocols and validation protocols.
5 To perform and document operations in accordance with cGMP.
6 Maintenance and calibration of production equipment and instrumentation in co-ordination
with maintenance department.
7 To comply with EHS policies and procedures.
8 Responsible for OTIF execution of all the activities related to Downstream (Buffer Preparation).
9 To ensure that all production deviation are reported and evaluated and that critical deviations
are investigated and the conclusions are recorded.
10 To ensure that the required initial and continuing training of PDS-Downstream personnel is
carried out and adapted according to need.
11 Preparation or modification of Batch Manufacturing Records, SOP, EOP, Checklists, Log
Sheets and related documents.
12. Data owner for process equipment used in day-to-day activityEducational QualificationsRequired Education Qualification: B.Sc
Required Experience: 1 - 5 years