QA Specialist – Quality Assurance (Level 3)
UPS · Santiago
Descripcion del puesto
About the role
This position monitors the overall Quality System status of a UPS distribution center, ensuring compliance with drug, medical device, and local regulations. The role involves implementing procedures, delivering training, and conducting regular inspections to maintain high quality standards.
Key responsibilities
- Train all staff on GMP and their specific job functions.
- Write and revise Standard Operating Procedures (SOPs) as needed.
- Perform regular facility inspections, record findings, and report summaries.
- Coordinate corrective and preventive actions and assist with change control requests.
- Communicate with clients during external audits and liaise with Health Canada officials.
- Provide QA support for customer inquiries and regulatory audits.
- Monitor departmental processes for regulatory compliance and operational effectiveness.
- Investigate discrepancies, prepare NCR reports, and drive continuous improvement of quality systems.
Required profile
- Bachelor’s degree in a science‑related field or internationally comparable qualification.
- Experience in pharmaceutical or medical‑device quality assurance.
- Familiarity with GMP, SOP development, and regulatory audit processes.
- QPIC/AQPIC designation is preferred.
Required skills
- Good Manufacturing Practices (GMP)
- Standard Operating Procedure (SOP) authoring
- Regulatory compliance and audit liaison
- NCR reporting and change control
- Quality System maintenance and continuous improvement
What we offer
- Opportunity to work within a Fortune Global 500 organization.
- Exposure to a collaborative, innovative culture.
- Professional development in a regulated environment.
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Publicado hace 1 mes
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UPS
Santiago
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