Essential Functions
-Provide operational support for product release to ensure it meets all quality and regulatory requirements when necessary.
-Conduct and support investigations for non-conformances, FAAs and customer complaints. Review and approve validation protocols and reports; ensure compliance with established procedures and sound validation methodology.
- Act as quality approvers for non conformances and site change controls.
-Provide e-compliance oversight to site CSV activities.
-Provide oversight to site NC CAPA process.
-Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment and associated deviations.
- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
-Support internal and external audits and is responsible for audit finding closure, as required. Work with cross-functional teams to resolve operational quality issues
-Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
-Support project teams as Quality Oversight for new product design transfer
-Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
-Performs any other duties as assigned by Supervisor according to business needs.
Education: Bachelor/ Degree in Science, Life Science, Engineering or other appropriate education and experience in pharmaceutical and medical device industry.
Experience: At least 5 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and Medical Device • Have good knowledge of cGMPs, ISO13485, 21 CFR Part 11 and/ or ISO9001 requirements. • Good experience in validation activities including CSV • Good Knowledge of Change Control, Document Control, Training Systems and/ or Non conformance systems will be of added advantage. • Must be able to work independently and have good decision making ability and interpersonal skill. • Must have strong communication skills, ability to work within and/or lead a team, with good problem solving skill.
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What We Do
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, 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 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care.
