Associate Lead - Quality Systems - Manufacturing

Duties and Responsibility : 

- Own, sustain and continually improve the site quality management system by executing the existing requirements and by driving improvement and simplification initiatives.

- Drive and implement all the globally driven initiatives/changes at the site in the areas of Quality Management System, Audits (Internal and External), Document and Record Control and CAPA.

- Collaborate with the extended global teams for participation indifferent global/site projects.

- Represent the site in different global/regional communities of practice.

- Facilitate the quarterly management reviews for the site along with the site management representative.

- Facilitate external audits with the notified body.

- Participate in quality planning for the site.

- Lead and conduct internal audits for the site.

- Guide and train users at the site for different quality management system related aspects.

- Drive awareness sessions in the space of quality management system for the site as identified.

- Lead the product data, product life cycle and document control activities and system for the site.

- Support the site users for all document control activities.

- Author and own all site documents in the space of Quality management system, Audits, Document and Record Control and CAPA.

- Maintain records as per the site/organization's record management process.

- Coordinate NCs and CAPAs for the site.

- Drive the Non-conformance and CAPA metrics and mentor record owners.

- Facilitate CAPA review board meetings for the site.

- Drive quality culture at the site through various trainings and other employee engagement activities.

Qualifications:- Bachelor of Engineering/ Bachelor of Technology