Manager, Quality Operations

Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.

Contributes to the site Quality Management System by ensuring its effective implementation in the organization through self-inspections, performance metrics and management reviews.

Establish and manage the processes for Computer System Validation (CSV) & Non-Conformances, including training effectiveness and oversight on execution. Provide e-compliance oversight to site CSV activities, and provide guidance and coaching to CSV SME.

Dive deep and maintain the technical understanding needed to actively contribute to engineering and product decision-making for both LS1 & DSM Flex platforms.

Provide oversight on all site validation activities, manufacturing projects, including laboratory equipment and method transfers, infrastructure, utilities and supporting functions.

Provide oversight, guidance & make informed decisions for expansion projects, technical transfers/ new design or design transfers etc within both platforms.

Participate in management of nonconformance & CAPA program to ensure timely follow-up, completion, documentation & disposition of products.

Perform, review and/or approve manufacturing operational activities, such as nonconformance (NC) investigation, CAPA, escalations, change requests, SOPs, Forms, MROM, IMR etc.

Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment, PLC changes, and associated deviations.

Oversee continuous monitoring activities and review key performance indicators, suggest improvements and escalate to supervisor/management as necessary.

Support in preparing, presenting and managing cost centre budget and forecast accuracy, including personnel cost.

Support internal and external audits, responsible for audit finding closure, as required. Work with cross-functional teams to resolve operational quality issues.

Perform internal quality audits (IQA) as auditor to ensure operational compliance.

Backup to the Senior Manager, Quality Operations, as required.

Performs any other duties as assigned by Supervisor according to business needs.

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