QUALITY SPECIALIST

Objective:

Inspects, monitors and documents the incoming and outgoing PMA products/materials/processes against established specifications and quality standards. Conducts tests, performs measurements, take samples and over sees production processes as per established acceptance criteria.

Specific Duties:

1. Perform quality inspection on all incoming materials from supplier/vendor and outgoing products for shipping.

2. Inspect all product for Good/Rejects and document all products & materials that fails to meet the quality expectations.

3. Identify, document, and report non-conformances and quality defects

4. Ensure segregation, labelling, and status identification of materials and products

5. Able to comprehend drawings and specifications related to incoming and outgoing product & materials to understand the requirements of acceptance criteria.

6. Perform product inspections such as dimension measurement, functionality test of the final product as per acceptance criteria.

7. Document all the device, production and performance records with each outcome during inspection with on time completion.

8. Ensure sample storage, labelling, and traceability

9. Monitor day-to-day compliance with ISO9001, ISO13485, MDA, cGMP, SOPs, and quality procedures on the shopfloor

10. Perform line clearance, area clearance, and hygiene inspections

11. Train production team on the quality control concerns whenever necessary.

12. Quality personnel to supervise the production process throughout production.

13. Perform visual inspection to check material/product/packaging are free from any type of damage, contamination, dirt or debris.

14. Able to handle multiple equipment used for quality inspection on the product.

15. Have basic knowledge about Quality Management System (QMS), Good Manufacturing Practises (GMP), Good Documentation Practices (GDP) and Cleanroom Environment condition and controls.

16. Able to train operators based on established work instructions and procedures on processes.

17. Responsible for following quality standards, safety, compliance, and company policies/practices.

18. Participate in quality improvement initiatives

19. Provide feedback to QA/QC teams on recurring issues and improvement opportunities

20. Perform other tasks, projects or duties as assigned by management whenever deemed necessary.

Qualifications

1. Bachelor’s degree in science, Chemistry, Microbiology, Pharmacy, or related field, Certification in quality control is preferred.

2. A minimum of 2 years’ experience

3. Working knowledge of MS Office.

4. Attention to detail with excellent technical and math skills.

5. Strong understanding of quality standards, testing and aseptic techniques.

6. Strong attention to detail and observational skills

7. Good understanding of cGMP and quality procedures

8. Ability to work on the shopfloor and handle routine inspections

9. Basic documentation and reporting skills

10. Good communication and coordination skills