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.
-Provide e-compliance oversight to site CSV activities.
-Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment and associated deviations.
-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.
-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.
Key performance indicators
1) Validation projects are completed as per timeline in compliance with Alcon standards, SOPs and regulatory requirements.
2) All activities have adequate QA oversight, completed as per timeline and in compliance with QM, SOP and other relevant requirements.
3) CORP/ QSP/ Alcon standards implementation and remediation are executed as per plan.
4) On time closure of audit findings.
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