he Packing Officer Medical Diagnostic Devices is responsible for planning, supervising and executing the primary and secondary packing operations of in vitro diagnostic (IVD) products such as lateral flow kits, ELISA kits and associated accessories. The role ensures packing is performed accurately, efficiently and in compliance with ISO 13485, cGMP and internal quality systems. The officer will oversee labeling, kitting, pouching, sealing, cartoning and final boxing activities while maintaining traceability and documentation throughout the process. The ideal candidate will possess experience in device or diagnostic packing operations and a strong understanding of cleanroom discipline, packing validation and inspection protocols.

Key Duties and Responsibilities:

1. Supervise the packing of diagnostic devices in accordance with approved SOPs, batch packing records (BPRs) and product-specific requirements.
2. Oversee activities such as labeling, assembly, pouch sealing, cartoning, shrink wrapping and boxing of finished goods.
3. Ensure packing components (labels, inserts, pouches, boxes) are verified and issued correctly for each batch.
4. Maintain batch traceability and compliance with packing specifications, coding standards and packaging integrity checks.
5. Review and approve packing documentation including BPRs, line clearance checklists and reconciliation reports.
6. Coordinate line clearance, component issuance and changeovers between product batches.
7. Ensure good housekeeping and adherence to cleanroom protocols in packing zones.
8. Support packaging validations (PQ), line trials and packaging material compatibility studies.
9. Train packing operators and assistants on proper handling of diagnostic components and compliance requirements.
10. Collaborate with QA and Regulatory Affairs to ensure packaging compliance for domestic and export markets.

Academic Qualifications:
Bachelor’s degree or Higher Diploma in Industrial Engineering, Pharmaceutical Technology, Packaging Science or a related technical field. Additional certification in ISO 13485 or cGMP is an advantage.

Experience and Competencies:

1. Minimum of 3–5 years of experience in packaging operations for medical devices, diagnostics, or pharmaceuticals.
2. Familiarity with packing processes for lateral flow assays, diagnostic kits, and sterile/cleanroom environments.
3. Knowledge of ISO 13485, cGMP, GDP, and labeling standards for IVDs.
4. Strong leadership, documentation, and process supervision skills.
5. Proficiency in reviewing packing records, reconciliation, and defect identification.

Ability to work cross-functionally with QA, QC, production, and regulatory teams.