Junior Officer QA

SUN PHARMA; Sungai Petani; On-site; MYR 50,000 - 84,000; Full time

Job summary

Sun Pharma Malaysia seeks an IPQA professional to oversee calibration of laboratory equipment, monitor environmental controls, and authorize necessary clearances for production lines and machines.

Key duties include sample collection, in-process quality checks, and ensuring GMP compliance across manufacturing activities. The role emphasizes accurate documentation of actions in EDMS/BRMS systems.

Qualifications

• Experience in in-process quality control and GMP compliance.
• Ability to perform calibration and monitoring of laboratory equipment.
• Familiarity with production line clearances and packaging instructions.

Responsibilities

• Perform internal calibration and monitor calibration of laboratory equipment in IPQA room as schedule.
• Monitor environment control and ensure compliance with GMP.
• Authorize clearance for machine setting and line clearance for production.
• Collect samples and ensure correct finished product, control, and stability samples.
• Ensure defects from in-process checks are addressed with corrective actions.

Skills

Calibration monitoring

GMP compliance

Line clearance

Sample collection

IPQA procedures

Tools

SAP HANA

BRMS

EDMS

Job description

• Responsible for compliance to IPQA activities at site.
• Responsible to ensure that there is no delay in production activity.

Essential Job Functions:

• Perform internal calibration and monitoring any calibration of laboratory equipment in IPQA room as per schedule.
• Monitoring environment control.
• Authorize clearance for machine setting.
• Authorize line clearance for production.
• Approval of coding details.
• Sample collection.
• Enhance effectiveness of in process quality control in order to improve product quality and investigation on market complaint.
• Ensure that all defects reported during in process checks have rectified, corrective actions taken and recorded.
• Observation and highlighting activity non-compliance to GMP.
• Verification of destruction of rejected/balances of packaging material in Production.
• Responsible for issuance of forms to production.
• Ensure online clearances of BPR timely and correctly
• Ensure sufficient man power and also coverage during the working hours and weekend.
• Ensure timely line clearances to production timely.
• Ensure adherence to SOP, Manufacturing Instruction & Packaging Instruction 100%.
• Ensure all in process control activity is performed as per regulated procedures and current GMP.
• Enhance effectiveness of in process quality control in order to improve product quality.
• Ensure sample collection made correctly as per the required quantity (finished product, control sample, stability sample, etc).
• Perform TRF sampling activity in SAP HANA system.
• Reconciler of EDMS forms.
• Reconciler of batch record in BRMS system.