QA Manager

254135BR
QA Manager
•To manage and lead all Quality and Regulatory activities at the affiliate, ensuring that all corporate policies and regulatory requirements are met in Alcon products and processes.
•Quality System - Develop, implement, maintain and updated the local Quality Management System (QMS), also covering all necessary cGMPs, GDP's, norms, regulations and standards related to the scope of the business.
•Facilitate and guide the generation of quality documentations from different areas of the company.
•Ensure that Corporate Procedures and Standards are properly deployed in to the local QMS.
•QM/QDs and IMPACD.
•Generate and maintain proper KPI's according QA needs and also requested by Division Manager (s).
•Responsible for the Scorecards and metrics monthly.
•Consolidate Annual Quality Plan according local business strategy and corporate quality.
•Ensure that Suppliers/Vendors and service contractors are properly approved and monitored in accordance with local procedures.
•Participate on internal and external audits guaranteeing that the proper support is provided.
•Provide QA Department information's to support local.
•Guarantee that products are storage properly, respecting their label statements, also handled, distributed and transported under their requirements.
•Be the local representative to perform the Market Actions and Recall.
•Responsible for initiating Escalations and attend/conduct presentation during the FAA meetings.
•Responsible for the Non-conformance process including conducting local investigation, root cause analysis, risk assessment and CAPAS.
•Responsible for the Change Control process and ensure good documentation practices.
•Responsible for performing Temperature Mapping at the Warehouse and Cooler and ensure monitoring, validation and re-qualification of any system in place, write protocol and technical reports.
•Responsible for implementing and maintaining the Training Program in Puerto Rico.
•Responsible for the Quality Risk Assessment for Puerto Rico.
•Responsible for the Calibration program and Preventative Maintenance.
•Responsible for maintaining the Good Distribution Practices and Housekeeping at the Warehouse and Cooler.
•Oversee the Warehousing activities performed by local Supply Chain and ensure GDP by running the temperature report weekly, having pest control activities in place.


Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
•Bachelor's degree or equivalent combination of education and relevant experience.
•English / Spanish
•5 Years of Relevant Experience
ALCON
COMMERCIAL NA AL
USA
San Juan
Alcon (Puerto Rico), Inc.
Quality
Full Time
Regular