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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