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.
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.
Find Jobs for Employees
Find Jobs for Contingent Worker
