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QA EXECUTIVES

PT GELFLEX INDONESIA

Contract

On Site

Job description

Production Support: Coordinate activities for product/batch issues and out-of-specification lenses. Provide first-level decisions for color matching/removal and escalate complex cases.

Non-Conformance Management: Handle issues from production processes and raise non-conformances as needed.

Equipment & Infrastructure Management: Ensure compliance with calibration, validation, and maintenance schedules. Manage internal/external calibrations, validations, pest control, IQ-OQ-PQ for equipment, and coordinate new/revised supply validations.

Documentation Control: Review and improve QA documentation to align with processes.

Product Sterilization: Validate sterilization processes and equipment. Address autoclave issues and vendor communications.

Quality Audits: Coordinate internal/external audits, create audit plans, train auditors, and manage NCR, CAPA, and supplier qualifications.

Incoming Inspections: Inspect raw materials and drymould, manage records, and address issues.

Master Maintenance: Oversee raw material, lens, and equipment masters, ensuring accuracy and availability.

Records & Administration: Maintain QA records, manage supplies, prepare certificates.


Job requirements

  • Education: Bachelor’s degree in a relevant field; QA certifications are a plus.
  • Experience: 2-3 years in QA within manufacturing, preferably contact lenses or medical devices. Knowledge of ISO 13485 and FDA regulations is preferred.
  • Technical Skills: Proficient in calibration, validation, equipment management, and sterilization processes (e.g., autoclave operations). Familiarity with SAP systems, documentation control, quality audits, NCR, CAPA, and inspection processes.
  • Soft Skills: Strong analytical, decision-making, organizational, and documentation skills. Effective communicator with leadership abilities.
  • Other Requirements: Willing to handle cross-functional tasks in a dynamic, fast-paced environment.

Benefits

  • Access to training and development programs to enhance technical and leadership skills.
  • Attractive salary package aligned with industry standards.
  • Collaborate with a skilled and supportive team in a fast-paced industry.
  • Exposure to cutting-edge technology and global quality standards like ISO and FDA compliance.

Job information

Education

Bachelor Degree (S1)

Experience level

Executive

Minimum experience

2 years

Gender

Female

Age range

17 years - 65 years

Published date

22 Nov 2024

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