Job Purpose:
This position is responsible for Quality Control (QC) laboratory operations, ensuring operations for Analytical, Microbiology, Stability, Validation Testing Lab (VTL) and QC inspection are within budget and compliant to Health Authorities and Alcon requirements.
Major Accountabilities
• Manage day-to-day activities for QC functions; ensure within planned budget.
• Provide direction and supervision to the QC associates. Conduct career dialogue with follow up on development plan.
• Ensure testing performed by QC labs is compliant to ISO 13485, MDSAP, EU MDR, Alcon
Standards and Policies, and regulatory requirement.
• Ensure equipment and testing methods used in QC labs are compliant to ISO 13485, MDSAP, EU MDR, Alcon Standards and Policies, and regulatory requirement.
• Drive Kaizen, continuous improvement and LEAN lab initiatives in QC to improve operation productivity and quality compliance.
• Ensure compliance with HSE guidelines, and local health and safety regulations in QC.
• Ensure timely completion of non-conformance investigation, CAPA implementation, effectiveness check, and assessments relate to QC function. Ensure sufficient certified NCR investigators in QC functions.
• Support NCR investigation as certified investigator or review & approve the investigation as QC supervisor. Ensure the investigations performed / approved are compliant to SOP requirements.
• Ensure assigned internal self-assessments are conducted as per schedule. Ensure internal self-assessments conducted are compliant with SOP requirements.
Education:
• Preferred Science, Engineering, Pharmacy, or equivalent degrees. Minimum Diploma in a related discipline combined with the relevant experience as detailed below.
Experience:
• 10 years in Quality Control, Laboratory testing and Medical Device or Pharmaceutical Manufacturing in a management capacity.
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.
