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Manager, quality operations
2 weeks ago
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a Quality Operations Manager, you will oversee and ensure that the manufacturing of medical devices produced meets the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR) and other applicable regulations and standards. This applies in all operational aspects, including but not limited to, site validation, Computer System Validation (CSV), risk management activities, non-conformance investigations, change requests, document review & approvals, etc.
In this role, a typical day will include:
Meet quality objectives set by management & comply with Alcon, QMS and Safety requirements.
Contribute 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 SMEs.
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.
Review and approve manufacturing operational activities, such as nonconformance, 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.
Responsible for quality evolution project pipeline, cost savings and continuous improvement within the quality function.
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 lead auditor to ensure operational compliance.
Backup to the Quality Operations Senior Manager, as required.
Perform any other duties as assigned by Supervisor according to business needs.
WHAT YOU’LL BRING TO ALCON:
Bachelor's Degree in Science, Life Science, Engineering or other appropriate education and experience in the pharmaceutical and medical device industry.Minimum 5 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and Medical Device with minimum leadership experience of 3 years with at least 5 direct reports.
Good knowledge of c GMPs, ISO 13485, 21 CFR Part 11 and/or ISO 9001 requirements.
Extensive 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.
HOW YOU CAN THRIVE AT ALCON:
Good team player.
Enjoy working with various cross-functional teams across the manufacturing site.
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