PRIMARY RESPONSIBILITIES:
A.GDP / GDPMD Operational Inspection & Compliance Monitoring
- Perform receiving inspection activities for products and operational compliance.
- a)Verify product condition, label integrity, batch information, and expiry details.
- b)Observe transportation cleanliness, segregation, and handling conditions.
- c)Conduct storage area inspections to ensure compliance with GDP/GDPMD requirements.
- d)Verify segregation practices (saleable, quarantine, rejected, class-based where applicable).
- e)Observe FIFO / FEFO implementation and warehouse housekeeping conditions.
- f)Conduct operational observations during picking, packing, handling, and dispatch activities.
- g)Report operational non-conformances and abnormalities identified during inspections.
- Temperature & Environmental Monitoring
- a)Maintain temperature and environmental monitoring records for warehouse and transportation activities.
- b)Perform temperature spot-check verification against monitoring records.
- c)Verify data logger placement and monitoring device condition.
- d)Check availability of alarm, excursion, and follow-up investigation records.
- e)Ensure monitoring records are complete, accurate, and audit-ready prior to submission.
- QA Documentation & Audit Support
- a)Maintain complete and accurate QA compliance records and supporting documentation.
- b)Support preparation and compilation of internal and external audit evidence.
- c)Assist in maintaining CAPA tracking and follow-up records.
- d)Ensure inspection records, checklists, and compliance documents are properly maintained.
- e)Support Management Review documentation and compliance reporting activities.
- f)Ensure records are verified, complete, and audit-ready before submission for approval.
- Traceability & Recall
- a)Maintain traceability logs and supporting documentation.
- b)Support mock recall exercises and physical verification activities.
- c)Maintain product recall execution records and supporting evidence.
- Pest Control & Environmental Monitoring
- a)Maintain pest control inspection records and monthly reports.
- b)Perform bait station inspection verification and monitoring activities.
- c)Maintain environmental monitoring and supporting inspection records.
- Supplier & Outsourced Activity Records
- a)Maintain supplier agreement and evaluation records.
- b)Maintain service provider records (transporters, pest control, calibration vendors, etc.).
- c)Ensure outsourced activity records are complete and properly maintained.
- Disposal & Compliance Record Support
- a)Maintain disposal records and supporting documentation.
- b)Support verification and filing of compliance-related operational records.
- c)Ensure proper retention and organization of QA compliance documentation.
B. Training Administration & Coordination Support
- Coordinate training logistics and scheduling as directed by QSC Manager.
- Maintain training attendance records and supporting documentation.
- Ensure completeness and accuracy of training records prior to submission.
- Support departmental compliance awareness and operational activities.
C. Occupational Safety & Health (SECONDARY ROLE)
- Assist in routine warehouse safety walkthrough inspections.
- Verify fire extinguisher accessibility and inspection tag validity.
- Observe housekeeping conditions and basic workplace safety compliance.
- Support PPE compliance and operational safety monitoring activities.
- Compile and organize OSH-related records and inspection documentation.
- Report unsafe conditions, documentation gaps, and operational safety concerns to QSC Manager.
- Support inspection and audit preparation related to OSH activities.
QUALIFICATION, EXPERIENCE & COMPETENCY REQUIREMENTS
A. Educational Background
- Minimum Diploma in any of the following disciplines:
- oQuality Assurance / Quality Management
- oOccupational Safety & Health
- oLogistics / Supply Chain Management
- oEngineering / Science
- oIndustrial or Manufacturing-related field
- (Candidates with SPM may be considered if they possess strong relevant experience in warehouse, QA, or safety inspection environments.)
B. Working Experience
- 1–3 years of experience in one or more of the following areas:
- oWarehouse operations (GDP / GDPMD / pharmaceutical / medical device environment preferred)
- oQuality inspection, compliance checks, or audit support
- oSafety inspection, site walkthrough, or operational monitoring
- Exposure to GDP, GDPMD, ISO 9001, or OSHA requirements is an advantage.
C. Technical Skills & Knowledge
- Basic understanding of:
- oGDP / GDPMD principles (product integrity, storage condition, traceability)
- oTemperature and environmental monitoring
- oInspection and checklist-based work
- Able to:
- oFollow SOPs, checklists, and work instructions accurately
- oIdentify and record non-conformances objectively
- oTake clear photographic evidence where required
- Basic computer skills:
- oMicrosoft Excel / Word
- oAbility to handle inspection records and simple trackers
D. Soft Skills & Behavioral Requirements
- Detail-oriented and disciplined in record completion
- Comfortable with routine inspection and on-floor activities
- Able to follow instructions and escalation pathways
- Willing to learn and apply compliance requirements
- Good observation and reporting skills
- Able to work independently with minimal supervision
E. Certificates & Training (Preferred, Not Mandatory)
- GDP or GDPMD awareness training
- Basic OSHA awareness
- First Aid or Fire Safety training (advantage)
- MHE awareness (if applicable to site)
- (Training can be provided for suitable candidates.)