Job Description

PRIMARY RESPONSIBILITIES:

A. GDP / GDPMD Operational Inspection & Compliance Monitoring

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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

1. Coordinate training logistics and scheduling as directed by QSC Manager.

2. Maintain training attendance records and supporting documentation.

3. Ensure completeness and accuracy of training records prior to submission.

4. Support departmental compliance awareness and operational activities.

C. Occupational Safety & Health (SECONDARY ROLE)

1. Assist in routine warehouse safety walkthrough inspections.

2. Verify fire extinguisher accessibility and inspection tag validity.

3. Observe housekeeping conditions and basic workplace safety compliance.

4. Support PPE compliance and operational safety monitoring activities.

5. Compile and organize OSH-related records and inspection documentation.

6. Report unsafe conditions, documentation gaps, and operational safety concerns to QSC Manager.

7. Support inspection and audit preparation related to OSH activities.

QUALIFICATION, EXPERIENCE & COMPETENCY REQUIREMENTS

A. Educational Background

• Minimum Diploma in any of the following disciplines:

o Quality Assurance / Quality Management

o Occupational Safety & Health

o Logistics / Supply Chain Management

o Engineering / Science

o Industrial 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:

o Warehouse operations (GDP / GDPMD / pharmaceutical / medical device environment preferred)

o Quality inspection, compliance checks, or audit support

o Safety 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:

o GDP / GDPMD principles (product integrity, storage condition, traceability)

o Temperature and environmental monitoring

o Inspection and checklist-based work

• Able to:

o Follow SOPs, checklists, and work instructions accurately

o Identify and record non-conformances objectively

o Take clear photographic evidence where required

• Basic computer skills:

o Microsoft Excel / Word

o Ability 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.)