Quality Assurance Systems Lead

3 weeks ago

Waterford, Ireland Bausch & Lomb Gmbh Full time

Select how often (in days) to receive an alert:
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life.
Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives.
Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history.
We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe.
We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Duties
Liaise with Shift Management to manage the Manufacturing operation to provide the required volume output per shift which complies with all quality and regulatory requirements.
Highlight relevant issues and participate/lead resolution
Determine appropriate lot disposition decisions on a shift by shift basis
Manage, review and approve any non-conformances that may occur
Act as the MQM interface with operations and engineering functions.
Disposition product as appropriate and manage any non-conformance activity
Ensure regulatory compliance to GMP's of applicable medical device regulatory agencies (e.g. FDA, ISO & MDD) and internal documentation
Provide direction to ensure product quality is maintained at all stages of the manufacturing operation.
Provide Shift direction on QA issues that occur within the shift.
Complete rationales for non-conformances as required.
The Manufacturing Quality Manager will specify additional requirements of the job.
Review, update and complete shift handover file.
Complete shiftly reviews of Bliss performance
On hold management – review on hold reports/inspection results constantly and manage actions to move product to disposition.
Attend and chair QA Tier meetings as required
Complete GMP/5S audits with operations and record results
The QA Shift Lead is instrumental in providing support to the Manufacturing QA Manager to ensure that the manufacturing operation produces product that meets specification within a manufacturing environment that complies with all relevant standards.
This role is a 4 shift position.
Requirements
Working Knowledge of Microsoft Office products – in particular excel is essential.
Working knowledge of Catsweb is desirable
Strong communication skills (Verbal & Written)
Strong organisational and administrative skills
Decisive, self-motivated/capable of working on own initiative, able to prioritise and a proactive approach.
High attention to detail
Self motivated with ability to handle multiple priorities.
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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